Product code DXN: 510(k) clearances and predicates
Product code DXN covers Upper Arm Blood pressure monitor (BP7155D). FDA lists 1225 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
1225 clearances on file under product code DXN. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 25 |
| 2023 | 35 |
| 2024 | 17 |
| 2025 | 28 |
| 2026 so far | 28 |
Recent clearances
Newest DXN clearances in the FDA index, with applicant and decision date:
- K261929, Upper Arm Blood pressure monitor (BP7155D), applicant OMRON Healthcare, Inc., decided 2026-09-10. FDA record
- K254000, Happy Health Blood Pressure Monitor, applicant Happy Health, Inc., decided 2026-09-03. FDA record
- K262658, Automatic Digital Blood Pressure monitor (LD-526), applicant Honsun (Nantong) Co., Ltd., decided 2026-08-31. FDA record
- K261394, Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus), applicant JOYTECH Healthcare Co., Ltd., decided 2026-08-26. FDA record
- K253425, Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P), applicant Joytech Healthcare Co. , Ltd., decided 2026-08-13. FDA record
- K261061, BP Go (BPP-855), applicant Wellvii, Inc., decided 2026-08-13. FDA record
- K261136, Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D), applicant Guangzhou Daxin Health Technology Co., Ltd., decided 2026-07-23. FDA record
- K261082, Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G), applicant Microlife Corporation, decided 2026-07-23. 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 Happy Health Blood Pressure Monitor, Automatic Digital Blood Pressure monitor (LD-526). Watch new DXN 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 DXN?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent DXN clearances include Upper Arm Blood pressure monitor (BP7155D).
How many 510(k) clearances use product code DXN?
1225 at the time this page was generated, from openFDA records.
How do I find a predicate device under DXN?
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 DXN 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.