Product code DPS: 510(k) clearances and predicates
Product code DPS covers S-Patch CardioAI. FDA lists 577 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
577 clearances on file under product code DPS. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 6 |
| 2023 | 10 |
| 2024 | 8 |
| 2025 | 6 |
| 2026 so far | 3 |
Recent clearances
Newest DPS clearances in the FDA index, with applicant and decision date:
- K254255, S-Patch CardioAI, applicant Wellysis Corp., decided 2026-09-25. FDA record
- K252463, SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E), applicant Edan Instruments, Inc., decided 2026-07-02. FDA record
- K251670, MAC 7 Resting ECG Analysis System, applicant Ge Medical Systems Information Technologies, Inc., decided 2026-01-26. FDA record
- K252361, AccurECG Analysis System (v2.0), applicant Accurkardia, Inc., decided 2025-12-22. FDA record
- K252474, Withings BeamO (SCT02), applicant Withings, decided 2025-11-10. FDA record
- K250569, Cardiologs Holter Platform, applicant Philips France Commercial, decided 2025-08-06. FDA record
- K243252, ZBPro Diagnostic, applicant Zbeats, Inc., decided 2025-07-10. FDA record
- K243305, Masimo W1, applicant Masimo Corporation, decided 2025-04-03. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E), MAC 7 Resting ECG Analysis System. Watch new DPS clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code DPS?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent DPS clearances include S-Patch CardioAI.
How many 510(k) clearances use product code DPS?
577 at the time this page was generated, from openFDA records.
How do I find a predicate device under DPS?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new DPS clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.