FDA product code · Cardiovascular
DPSElectrocardiograph
Product code DPS covers Electrocardiograph, a Class II device regulated under 21 CFR 870.2340. FDA has cleared 576 devices in this code, 4 of them in the last 12 months. Median review time across the 576 most recent decisions is 105 days. openFDA lists 95 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 870.2340
- Review panel
- Cardiovascular
- Clearances
- 576
What is happening in DPS right now?
DPS (Electrocardiograph) has two findings, most consequential first. 4 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2876-2026, Z-0165-2026, Z-0166-2026, Z-0231-2026). The code is crowded, scoring 72 of 100 — 262 companies hold a clearance here and 4 arrived in the last 12 months (DPS:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2876-2026, Z-0165-2026, Z-0166-2026, Z-0231-2026 |
| Crowding | Context | DPS: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 DPS?
FDA has cleared 576 devices under product code DPS since the 510(k) programme began in 1976, 4 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) | Edan Instruments, Inc. | |
| K251670 | MAC 7 Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | |
| K252361 | AccurECG Analysis System (v2.0) | Accurkardia, Inc. | |
| K252474 | Withings BeamO (SCT02) | Withings | |
| K250569 | Cardiologs Holter Platform | Philips France Commercial | |
| K243252 | ZBPro Diagnostic | Zbeats, Inc. | |
| K243305 | Masimo W1 | Masimo Corporation | |
| K241217 | CloudHRV System (100-01-001) | Inmedix, Inc. | |
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000) | Philips Medizin Systeme Böblingen GmbH | |
| K240229 | Masimo W1 | Masimo Corporation |
How long does FDA review take for DPS?
The median FDA review time for DPS is 105 days, measured across the 576 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 DPS?
openFDA lists 95 recall records against product code DPS. A recall record covers one firm's corrective action and may span many device lots.
Z-2876-2026Open, ClassifiedGE Medical Systems Information Technologies, Inc.
Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a previous patient may remain on the screen and could be incorrectly associated with a subsequent patient.
Z-0165-2026Open, ClassifiedPhilips North America LLC
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
Z-0166-2026Open, ClassifiedPhilips North America LLC
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
Z-0231-2026Open, ClassifiedGE Medical Systems, LLC
If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use.
Z-1560-2025Open, ClassifiedBaxter Healthcare Corporation
There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
Showing the 5 most recently initiated of 95. 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 DPS?
MAUDE holds 163 adverse-event reports naming product code DPS, 26 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 DPS unusual?
One month sits above DPS's own expected range: 1 May 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | 0–10 | Within expected (0–10) | |
| 2 | 0–8 | Within expected (0–8) | |
| 2 | 0–9 | Within expected (0–9) | |
| 3 | 0–9 | Within expected (0–9) | |
| 20 | 0–8 | Above expected (0–8) | |
| 1 | 0–19 | Within expected (0–19) | |
| 3 | 0–28 | Within expected (0–28) | |
| 5 | 0–18 | Within expected (0–18) | |
| 5 | 0–19 | Within expected (0–19) | |
| 7 | 0–19 | Within expected (0–19) | |
| 5 | 0–17 | Within expected (0–17) | |
| 1 | 0–19 | Within expected (0–19) | |
| 1 | 0–20 | Within expected (0–20) | |
| 3 | Insufficient history | No expected range — too little history |
22 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 DPS.
What are the predicate devices in DPS?
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 DPS?
Across the 576 most recent decisions, these applicants filed most often in DPS.
| Applicant | Recent clearances |
|---|---|
| Mortara Instrument, Inc. | 21 |
| Nihon Kohden America, Inc. | 21 |
| Edan Instruments, Inc. | 19 |
| Quinton, Inc. | 17 |
| Hewlett-Packard Co. | 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 DPS 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 | 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 DPS
Get an email the morning anything changes in DPS — 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.