Product code DXH: 510(k) clearances and predicates
Product code DXH covers PreemptiveAI Clinical SDK. FDA lists 297 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
297 clearances on file under product code DXH. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 4 |
| 2023 | 1 |
| 2024 | 0 |
| 2025 | 4 |
| 2026 so far | 1 |
Recent clearances
Newest DXH clearances in the FDA index, with applicant and decision date:
- K250233, PreemptiveAI Clinical SDK, applicant Measure Labs, Inc. (Dba Preemptiveai, Inc.), decided 2026-02-13. FDA record
- K250258, HeartBeam AIMIGo with 12-L ECG Synthesis Software System, applicant Heartbeam, Inc., decided 2025-12-08. FDA record
- K243438, MEMO Patch M (MPT-E08R-UNC01), applicant Huinno Co., Ltd., decided 2025-12-05. FDA record
- K243981, Hexoskin Medical System (7100-00016), applicant Carre Technologies, Inc., decided 2025-11-18. FDA record
- K243003, VitalSigns 1-Lead Holter (VSH101), applicant VitalSigns Technology Co., Ltd., decided 2025-06-17. FDA record
- K233521, QT ECG (QTERD100), applicant QT Medical, Inc., decided 2023-12-06. FDA record
- K222842, V-Patch Cardiac Monitor, applicant Shandong Corecare Technology Limited, decided 2022-10-20. FDA record
- K220795, QT ECG, applicant QT Medical, Inc., decided 2022-09-26. 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 HeartBeam AIMIGo with 12-L ECG Synthesis Software System, MEMO Patch M (MPT-E08R-UNC01). Watch new DXH 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 DXH?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent DXH clearances include PreemptiveAI Clinical SDK.
How many 510(k) clearances use product code DXH?
297 at the time this page was generated, from openFDA records.
How do I find a predicate device under DXH?
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 DXH 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.