Product code DSH: 510(k) clearances and predicates
Product code DSH covers LifeLens Physiological Monitor. FDA lists 195 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
195 clearances on file under product code DSH. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 4 |
| 2023 | 6 |
| 2024 | 2 |
| 2025 | 4 |
| 2026 so far | 2 |
Recent clearances
Newest DSH clearances in the FDA index, with applicant and decision date:
- K260157, LifeLens Physiological Monitor, applicant LifeLens Technologies, Inc., decided 2026-07-09. FDA record
- K252389, Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX), applicant Smwmed, Inc., decided 2026-04-23. FDA record
- K253293, VitaloJAK Clinic (Model 7100), applicant Vitalograph , Ltd., decided 2025-12-03. FDA record
- K243650, Zio® monitor (DFG0001), applicant iRhythm Technologies, Inc., decided 2025-08-15. FDA record
- K243603, AeviceMD, applicant Aevice Health Pte. , Ltd., decided 2025-05-05. FDA record
- K242583, AT-Patch (ATP-C130/ATP-C70), applicant Atsens Co., Ltd., decided 2025-05-02. FDA record
- K232670, HiCardi+ H100, applicant MEZOO Co., Ltd., decided 2024-09-20. FDA record
- K233906, S-Patch (S-Patch ExL), applicant Wellysis Corp., decided 2024-02-16. 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 Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX), VitaloJAK Clinic (Model 7100). Watch new DSH 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 DSH?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent DSH clearances include LifeLens Physiological Monitor.
How many 510(k) clearances use product code DSH?
195 at the time this page was generated, from openFDA records.
How do I find a predicate device under DSH?
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 DSH clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.