Product code BTM: 510(k) clearances and predicates
Product code BTM covers The BAG manual resuscitator and accessories. FDA lists 209 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
209 clearances on file under product code BTM. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 0 |
| 2025 | 2 |
| 2026 so far | 0 |
Recent clearances
Newest BTM clearances in the FDA index, with applicant and decision date:
- K251631, The BAG manual resuscitator and accessories, applicant Laerdal Medical AS, decided 2025-11-24. FDA record
- K243861, butterflyBVM, applicant Compact Medical, Inc., decided 2025-04-25. FDA record
- K221841, EOlife®, applicant Archeon, decided 2023-03-18. FDA record
- K212905, Sotair Device, applicant Safe Bvm Corporation, decided 2022-08-18. FDA record
- K210288, Disposable Manual Resuscitator, applicant Xiamen Compower Medical Tech. Co., Ltd., decided 2021-08-26. FDA record
- K181583, Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20, applicant Flexicare Medical Limited., decided 2018-12-07. FDA record
- K170663, Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer, applicant Foremount Enterprise Co., Ltd., decided 2018-05-11. FDA record
- K152931, Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator, applicant Ambu A/S, decided 2016-08-29. 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 butterflyBVM, EOlife®. Watch new BTM 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 BTM?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent BTM clearances include The BAG manual resuscitator and accessories.
How many 510(k) clearances use product code BTM?
209 at the time this page was generated, from openFDA records.
How do I find a predicate device under BTM?
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 BTM 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.