FDA product code · Cardiovascular
DQKComputer, Diagnostic, Programmable
Product code DQK covers Computer, Diagnostic, Programmable, a Class II device regulated under 21 CFR 870.1425. FDA has cleared 435 devices in this code, 29 of them in the last 12 months. Median review time across the 435 most recent decisions is 103 days. openFDA lists 124 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 870.1425
- Review panel
- Cardiovascular
- Clearances
- 435
What is happening in DQK right now?
DQK (Computer, Diagnostic, Programmable) has three findings, most consequential first. 3 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2279-2026, Z-0416-2026, Z-2518-2025). 6 first-time filers in the last 12 months, including Analytics For Life, Inc. and Synergen Technology Labs, LLC (K253576, K252978, K253088, K253861, K251218). The code is crowded, scoring 99 of 100 — 180 companies hold a clearance here and 29 arrived in the last 12 months (DQK:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2279-2026, Z-0416-2026, Z-2518-2025 |
| New entrant | Worth knowing | K253576, K252978, K253088, K253861, K251218 |
| Crowding | Context | DQK:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in DQK?
FDA has cleared 435 devices under product code DQK since the 510(k) programme began in 1976, 29 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253576 | CorVista System® with PCWP Add-On | Analytics For Life, Inc. | |
| K262006 | EnSite X EP System | Abbott Medical | |
| K252978 | ScioCardio ECG Analysis Platform | Synergen Technology Labs, LLC | |
| K253463 | ILR ECG Analyzer (IM007) | Implicity, Inc. | |
| K261119 | NorthStar Mapping System (MAP01 or MAP01-01) | Imricor Medical Systems, Inc. | |
| K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO) | Micropace Pty, Ltd. | |
| K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035) | Centerline Biomedical | |
| K252859 | ZEUS Platform (FG0501US) | iRhythm Technologies, Inc. | |
| K260212 | EnSite X EP System | ABBOTT MEDICAL | |
| K253861 | ACORYS MAPPING SYSTEM | Corify Care S.L |
How long does FDA review take for DQK?
The median FDA review time for DQK is 103 days, measured across the 435 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in DQK?
openFDA lists 124 recall records against product code DQK. A recall record covers one firm's corrective action and may span many device lots.
Z-2279-2026Open, ClassifiedGE Medical Systems Information Technologies, Inc.
Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparking at the printer head can result in charring or discoloration of thermal printer paper. Ignition of the paper could potentially result in serious thermal injury.
Z-0416-2026Open, ClassifiedSpacelabs Healthcare, Inc.
Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm ECG functionality, under specific navigation conditions, test data intended for one patient may be saved under another patient's record
Z-2518-2025Open, ClassifiedMerge Healthcare Incorporated
Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units trigger an error message on the Merge Hemo Client (Pressure Sensor Defective) during non-invasive blood pressure (NIBP) measurements, specifically when the initial inflation pressure is set in the high-pressure range (>240 mmHg). The ARGUS PB-3000 is a vital signs monitoring instrument intended to be integrated into the Merge Hemo System. No other components of the Merge Hemo System are affected.
Z-1760-2025Open, ClassifiedCenterline Biomedical Inc
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
Z-0095-2025Open, ClassifiedBoston Scientific Corporation
Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while in either Live or Record mode. The Boston Scientific investigation determined that, due to a software anomaly, a 9-grid mark overlay is incorrectly displayed during Live mode when AVVIGO+ is connected to an OptiCross 18 Peripheral Imaging Catheter. Note that the correct overlay display for this catheter is the 15-grid mark overlay, which allows for a reference depth setting of 14.9mm for peripheral catheters. This software anomaly is limited to Live or Record mode. In Review mode, the correct 15-grid mark overlay is displayed, and the vessel image is correctly scaled to the appropriate size.
Showing the 5 most recently initiated of 124. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for DQK?
MAUDE holds 1,368 adverse-event reports naming product code DQK, 307 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in DQK unusual?
Every month with enough history behind it falls inside DQK's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 20 | Insufficient history | No expected range — too little history | |
| 38 | Insufficient history | No expected range — too little history | |
| 29 | Insufficient history | No expected range — too little history | |
| 25 | Insufficient history | No expected range — too little history | |
| 25 | Insufficient history | No expected range — too little history | |
| 33 | Insufficient history | No expected range — too little history | |
| 25 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 26 | Insufficient history | No expected range — too little history | |
| 31 | Insufficient history | No expected range — too little history | |
| 22 | Insufficient history | No expected range — too little history | |
| 25 | Insufficient history | No expected range — too little history | |
| 27 | Insufficient history | No expected range — too little history | |
| 50 | Insufficient history | No expected range — too little history | |
| 27 | Insufficient history | No expected range — too little history | |
| 35 | Insufficient history | No expected range — too little history | |
| 51 | Insufficient history | No expected range — too little history | |
| 40 | Insufficient history | No expected range — too little history | |
| 136 | Insufficient history | No expected range — too little history | |
| 61 | Insufficient history | No expected range — too little history | |
| 52 | Insufficient history | No expected range — too little history | |
| 60 | 4–107 | Within expected (4–107) | |
| 32 | 4–94 | Within expected (4–94) | |
| 37 | 1–98 | Within expected (1–98) | |
| 31 | 0–96 | Within expected (0–96) | |
| 38 | 0–85 | Within expected (0–85) | |
| 28 | 0–88 | Within expected (0–88) | |
| 19 | 0–132 | Within expected (0–132) | |
| 20 | 0–95 | Within expected (0–95) | |
| 32 | 0–98 | Within expected (0–98) | |
| 32 | 0–100 | Within expected (0–100) | |
| 56 | 0–60 | Within expected (0–60) | |
| 38 | 7–74 | Within expected (7–74) | |
| 40 | 9–84 | Within expected (9–84) | |
| 51 | 13–62 | Within expected (13–62) | |
| 47 | 17–73 | Within expected (17–73) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in DQK.
Who has entered DQK in the last year?
6 companies filed in DQK for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Analytics For Life, Inc. | K253576 | |
| Synergen Technology Labs, LLC | K252978 | |
| Micropace Pty, Ltd. | K253088 | |
| Corify Care S.L | K253861 | |
| SafeBeat Rx, Inc. | K251218 | |
| Imricor Medical Systems, Inc. | K252164 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in DQK?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in DQK?
Across the 435 most recent decisions, these applicants filed most often in DQK.
| Applicant | Recent clearances |
|---|---|
| Biosense Webster, Inc. | 34 |
| St Jude Medical | 23 |
| ABBOTT MEDICAL | 12 |
| Acutus Medical, Inc. | 12 |
| Edwards Lifesciences, LLC | 12 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
3 companies in DQK file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| GE Medical Systems Information Technologies, Inc. | 18 | 3 |
| Edwards Lifesciences, LLC | 15 | 2 |
| Boston Scientific Corporation | 14 | 3 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch DQK
Get an email the morning anything changes in DQK — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
Related product codes in Cardiovascular
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.