FDA product code · Cardiovascular
DSIDetector And Alarm, Arrhythmia
Product code DSI covers Detector And Alarm, Arrhythmia, a Class II device regulated under 21 CFR 870.1025. FDA has cleared 398 devices in this code, 1 of them in the last 12 months. Median review time across the 398 most recent decisions is 117 days. openFDA lists 82 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 870.1025
- Review panel
- Cardiovascular
- Clearances
- 398
What is happening in DSI right now?
DSI (Detector And Alarm, Arrhythmia) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2052-2026, Z-1793-2026, Z-0849-2026, Z-0850-2026, Z-0851-2026). 1 first-time filer in the last 12 months, Boston Scientific Cardiac Diagnostic Technologies, Inc (K243349). The code is crowded, scoring 68 of 100 — 135 companies hold a clearance here and 1 arrived in the last 12 months (DSI:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2052-2026, Z-1793-2026, Z-0849-2026, Z-0850-2026, Z-0851-2026 |
| New entrant | Worth knowing | K243349 |
| Crowding | Context | DSI: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 DSI?
FDA has cleared 398 devices under product code DSI since the 510(k) programme began in 1976, 1 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243349 | BodyGuardian Remote Monitoring System (BGRMS v3.0) | Boston Scientific Cardiac Diagnostic Technologies, Inc. | |
| K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) | Infobionic, Inc. | |
| K240177 | Zio AT® device (A100A1001) | iRhythm Technologies, Inc. | |
| K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System | Infobionic, Inc. | |
| K231276 | SmartCardia 7L Platform | Smartcardia SA | |
| K193104 | Unified Arrhythmia Diagnostic System PocketECG IV | Medicalgorithmics S.A. | |
| K192732 | BodyGuardian Remote Monitoring System | Preventice Technologies, Inc. | |
| K190574 | Patient Assistant Model PA97000 | Medtronic, Inc. | |
| K182532 | Liba3 System | National Cardiac, Inc. | |
| K181658 | MobileECG 2 BT | Memtec Corporation |
How long does FDA review take for DSI?
The median FDA review time for DSI is 117 days, measured across the 398 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 DSI?
openFDA lists 82 recall records against product code DSI. A recall record covers one firm's corrective action and may span many device lots.
Z-2052-2026Open, ClassifiedSpacelabs Healthcare, Inc.
Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
Z-1793-2026Open, ClassifiedSpacelabs Healthcare, Inc.
Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO measurement not automatically excluded, which may result in inaccurate readings, or the need of additional readings, which may lead to delayed care and/or fluid overload.
Z-0849-2026Open, ClassifiedPhilips North America LLC
Potential issue where the IntelliVue monitors did not alarm.
Z-0850-2026Open, ClassifiedPhilips North America LLC
Potential issue where the IntelliVue monitors did not alarm.
Z-0851-2026Open, ClassifiedPhilips North America LLC
Potential issue where the IntelliVue monitors did not alarm.
Showing the 5 most recently initiated of 82. 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 DSI?
MAUDE holds 3,373 adverse-event reports naming product code DSI, 273 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 DSI unusual?
Every month with enough history behind it falls inside DSI's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 108 | Insufficient history | No expected range — too little history | |
| 111 | Insufficient history | No expected range — too little history | |
| 126 | Insufficient history | No expected range — too little history | |
| 140 | Insufficient history | No expected range — too little history | |
| 165 | Insufficient history | No expected range — too little history | |
| 136 | Insufficient history | No expected range — too little history | |
| 124 | Insufficient history | No expected range — too little history | |
| 130 | Insufficient history | No expected range — too little history | |
| 163 | Insufficient history | No expected range — too little history | |
| 101 | Insufficient history | No expected range — too little history | |
| 125 | Insufficient history | No expected range — too little history | |
| 184 | Insufficient history | No expected range — too little history | |
| 108 | Insufficient history | No expected range — too little history | |
| 137 | Insufficient history | No expected range — too little history | |
| 94 | Insufficient history | No expected range — too little history | |
| 107 | Insufficient history | No expected range — too little history | |
| 88 | Insufficient history | No expected range — too little history | |
| 116 | Insufficient history | No expected range — too little history | |
| 94 | Insufficient history | No expected range — too little history | |
| 90 | Insufficient history | No expected range — too little history | |
| 76 | Insufficient history | No expected range — too little history | |
| 85 | 22–148 | Within expected (22–148) | |
| 78 | 19–130 | Within expected (19–130) | |
| 85 | 24–147 | Within expected (24–147) | |
| 109 | 54–120 | Within expected (54–120) | |
| 75 | 57–119 | Within expected (57–119) | |
| 47 | 63–111 | Below expected (63–111) | |
| 35 | 67–168 | Below expected (67–168) | |
| 34 | 15–125 | Within expected (15–125) | |
| 37 | 0–130 | Within expected (0–130) | |
| 28 | 0–122 | Within expected (0–122) | |
| 48 | 0–109 | Within expected (0–109) | |
| 31 | 0–121 | Within expected (0–121) | |
| 28 | 0–138 | Within expected (0–138) | |
| 36 | 0–112 | Within expected (0–112) | |
| 41 | 0–117 | Within expected (0–117) |
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 DSI.
Who has entered DSI in the last year?
One company filed in DSI for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Boston Scientific Cardiac Diagnostic Technologies, Inc. | K243349 |
"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 DSI?
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 DSI?
Across the 398 most recent decisions, these applicants filed most often in DSI.
| Applicant | Recent clearances |
|---|---|
| Siemens Medical Solutions USA, Inc. | 27 |
| Fukuda Denshi USA, Inc. | 19 |
| Nihon Kohden America, Inc. | 18 |
| Hewlett-Packard Co. | 17 |
| Oxford Medilog, Inc. | 14 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in DSI files 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 |
|---|---|---|
| Hewlett-Packard GmbH | 22 | 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 DSI
Get an email the morning anything changes in DSI — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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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.