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510(k) K243861

butterflyBVM by Compact Medical, Inc. — Product Code BTM

K243861 is an FDA 510(k) premarket notification submitted by Compact Medical, Inc. for the device "butterflyBVM". The FDA issued a decision of Substantially Equivalent on April 25, 2025. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2025
Date Received
December 16, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Manual (Resuscitator)
Device Class
Class II
Regulation Number
868.5915
Review Panel
AN
Submission Type

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  • K212905 — Sotair Device (August 18, 2022)
  • K210288 — Disposable Manual Resuscitator (August 26, 2021)
  • K181583 — Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resu (December 7, 2018)
  • K170663 — Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremoun (May 11, 2018)
  • K152931 — Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR (August 29, 2016)
  • K132172 — NEONATALIE RESUSCITATOR (January 15, 2015)
  • K112852 — BABI PLUS NEONATAL RESUSCITATION BAG (January 13, 2012)
  • K102824 — AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC (January 28, 2011)

FDA data resources