Class Class II
butterflyBVM (K243861)
Description
butterflyBVM by Compact Medical, Inc., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243861
Clearance Date2025-04-25
Clearance TypeTraditional
Product CodeBTM
Regulation Number868.5915
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243861
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. butterflyBVM (K243861) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K152931 | Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Res... | Ambu A/S | 2016 |
Trace the full predicate network for K243861
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.