Home / 510(k) Clearances / K873286

510(k) K873286

DISPOSABLE, MANUAL PULMONARY RESUSCITATOR by Hospitak, Inc. — Product Code BTM

K873286 is an FDA 510(k) premarket notification submitted by Hospitak, Inc. for the device "DISPOSABLE, MANUAL PULMONARY RESUSCITATOR". The FDA issued a decision of Substantially Equivalent on October 26, 1987. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Hospitak, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1987
Date Received
August 17, 1987
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

Other clearances by Hospitak, Inc.

  • K955483 — TRACH MASK MODEL (245, 246) (February 28, 1996)
  • K954787 — ILLUMINATOR (January 31, 1996)
  • K953620 — WARM N WET HMEF W/LUER ADAPTER (August 25, 1995)
  • K953619 — WARM N WET HME W/LUER ADAPTER (August 25, 1995)
  • K915750 — DISPOSABLE BACTERIAL BREATHNG FILTER (November 30, 1994)
  • K920842 — AEROSOL DELIVERY SYSTEMS (May 15, 1992)
  • K915228 — DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNUL (February 11, 1992)
  • K853600 — INFLATABLE AIR SPLINTS (September 19, 1985)
  • K844328 — OXYGEN CONCENTRATOR (December 4, 1984)
  • K843212 — LOW PRESSURE ALARM FOR OXYGEN CYLINDER (September 19, 1984)

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