butterflyBVM— 510(k) K243861
Substantially EquivalentCompact Medical, Inc.
FDA 510(k) clearance K243861 for butterflyBVM, Substantially Equivalent on 2025-04-25. Applicant: Compact Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Compact Medical, Inc.
- Product code
- Code BTM
- Device class
- Class 2
- Regulation
- 21 CFR 868.5915
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code BTM
view all- K251631 — The BAG manual resuscitator and accessories
- K221841 — EOlife®
- K212905 — Sotair Device
- K210288 — Disposable Manual Resuscitator
- 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
Adverse events under product code BTM
product code BTM- Death
- 19
- Other
- 2
- Total
- 21
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.