FDA product code · Cardiovascular
DQOCatheter, Intravascular, Diagnostic
Product code DQO covers Catheter, Intravascular, Diagnostic, a Class II device regulated under 21 CFR 870.1200. FDA has cleared 501 devices in this code, 3 of them in the last 12 months. Median review time across the 501 most recent decisions is 88 days. openFDA lists 284 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 870.1200
- Review panel
- Cardiovascular
- Clearances
- 501
What is happening in DQO right now?
DQO (Catheter, Intravascular, Diagnostic) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class I, Class II) (Z-1934-2026, Z-1935-2026, Z-1936-2026, Z-1823-2026, Z-1778-2026). 2 first-time filers in the last 12 months, Bioptimal International Pte. , Ltd. and Spectrum Vascular (K252702, K254278). The code is crowded, scoring 81 of 100 — 194 companies hold a clearance here and 3 arrived in the last 12 months (DQO:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class I recall | Z-1934-2026, Z-1935-2026, Z-1936-2026, Z-1823-2026, Z-1778-2026 |
| New entrant | Worth knowing | K252702, K254278 |
| Crowding | Context | DQO: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 DQO?
FDA has cleared 501 devices under product code DQO since the 510(k) programme began in 1976, 3 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261455 | Arterial Pressure Monitoring Set/Tray | Spectrum Vascular | |
| K252702 | Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N | Bioptimal International Pte. , Ltd. | |
| K254278 | Arterial Pressure Monitoring Set/Tray | Spectrum Vascular | |
| K250751 | DualView Catheter | Terumo Corporation | |
| K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter | Gentuity, LLC | |
| K242420 | pNOVUS 21 Microcatheter | Phenox, Ltd. | |
| K233268 | Impress Angiographic Catheter | Merit Medical Systems, Inc. | |
| K233975 | Zoom 6F Insert Catheters | Imperative Care, Inc. | |
| K232536 | Soldier Microcatheter | Embolx, Inc. | |
| K232573 | INFINITI Ambi Angiographic Catheter | Cordis US Corp |
How long does FDA review take for DQO?
The median FDA review time for DQO is 88 days, measured across the 501 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 DQO?
openFDA lists 284 recall records against product code DQO. A recall record covers one firm's corrective action and may span many device lots.
Z-1934-2026Open, ClassifiedCook Incorporated
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
Z-1935-2026Open, ClassifiedCook Incorporated
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
Z-1936-2026Open, ClassifiedCook Incorporated
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
Z-1823-2026Open, ClassifiedGentuity, LLC
The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This correction is intended to ensure that users are fully informed of how to recognize, avoid, and mitigate this condition to maintain accurate longitudinal (length) measurements during OCT imaging.
Z-1778-2026Open, ClassifiedCook Incorporated
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Showing the 5 most recently initiated of 284. 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 DQO?
MAUDE holds 1,642 adverse-event reports naming product code DQO, 503 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 DQO unusual?
2 months sit above DQO's own expected range: 1 May 2025, 1 November 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 27 | Insufficient history | No expected range — too little history | |
| 18 | Insufficient history | No expected range — too little history | |
| 37 | Insufficient history | No expected range — too little history | |
| 22 | Insufficient history | No expected range — too little history | |
| 40 | Insufficient history | No expected range — too little history | |
| 30 | Insufficient history | No expected range — too little history | |
| 33 | Insufficient history | No expected range — too little history | |
| 34 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 42 | Insufficient history | No expected range — too little history | |
| 46 | Insufficient history | No expected range — too little history | |
| 26 | Insufficient history | No expected range — too little history | |
| 32 | Insufficient history | No expected range — too little history | |
| 43 | Insufficient history | No expected range — too little history | |
| 35 | Insufficient history | No expected range — too little history | |
| 56 | Insufficient history | No expected range — too little history | |
| 40 | Insufficient history | No expected range — too little history | |
| 44 | Insufficient history | No expected range — too little history | |
| 35 | Insufficient history | No expected range — too little history | |
| 40 | Insufficient history | No expected range — too little history | |
| 72 | Insufficient history | No expected range — too little history | |
| 29 | 25–65 | Within expected (25–65) | |
| 35 | 17–53 | Within expected (17–53) | |
| 49 | 19–59 | Within expected (19–59) | |
| 43 | 23–64 | Within expected (23–64) | |
| 65 | 23–59 | Above expected (23–59) | |
| 51 | 25–74 | Within expected (25–74) | |
| 66 | 41–118 | Within expected (41–118) | |
| 51 | 28–85 | Within expected (28–85) | |
| 51 | 28–88 | Within expected (28–88) | |
| 68 | 26–85 | Within expected (26–85) | |
| 88 | 28–78 | Above expected (28–78) | |
| 47 | 36–106 | Within expected (36–106) | |
| 102 | 34–112 | Within expected (34–112) | |
| 43 | 36–103 | Within expected (36–103) | |
| 66 | 30–105 | Within expected (30–105) |
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 DQO.
Who has entered DQO in the last year?
2 companies filed in DQO for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Bioptimal International Pte. , Ltd. | K252702 | |
| Spectrum Vascular | K254278 |
"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 DQO?
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 DQO?
Across the 501 most recent decisions, these applicants filed most often in DQO.
| Applicant | Recent clearances |
|---|---|
| Cordis Corp. | 28 |
| Boston Scientific Corp | 19 |
| C.R. Bard, Inc. | 16 |
| Scimed Life Systems, Inc. | 16 |
| AngioDynamics, Inc. | 11 |
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 DQO 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 |
|---|---|---|
| Cordis Corporation | 29 | 2 |
| Boston Scientific Corporation | 20 | 2 |
| Cook Incorporated | 15 | 2 |
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 DQO
Get an email the morning anything changes in DQO — 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.