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510(k) K012842

V*CARE MANUAL RESUSCITATOR by Ventlab Corp. — Product Code BTM

K012842 is an FDA 510(k) premarket notification submitted by Ventlab Corp. for the device "V*CARE MANUAL RESUSCITATOR". The FDA issued a decision of Substantially Equivalent on September 18, 2001. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Ventlab Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2001
Date Received
August 23, 2001
Clearance Type
Special
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

Other clearances by Ventlab Corp.

  • K173373 — SafeT T-Piece Resuscitator (November 16, 2018)
  • K120118 — VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER (May 24, 2012)
  • K102674 — CUFF SENTRY (July 22, 2011)
  • K093617 — VENTLAB 6000 SERIES HUMIDIFIER (January 27, 2011)
  • K093525 — ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT (December 10, 2009)
  • K090840 — VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN. (June 25, 2009)
  • K082204 — SERIES SY DISPOSABLE ELECTROSURGICAL PAD (August 13, 2008)
  • K063813 — VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA (March 26, 2008)
  • K040726 — VENTLAB NASAL CPAP CANNULA (June 3, 2004)
  • K030271 — VENTLAB BACTERIAL FILTER, MODEL BF100 (July 7, 2003)

Other clearances for product code BTM

  • K251631 — The BAG manual resuscitator and accessories (November 24, 2025)
  • K243861 — butterflyBVM (April 25, 2025)
  • K221841 — EOlife® (March 18, 2023)
  • 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)

FDA data resources