BTM · Class II · 21 CFR 868.5915

FDA Product Code BTM: Ventilator, Emergency, Manual (resuscitator)

Leading manufacturers include Ambu, Inc., Puritan Bennett Corp. and Medical Marketing Concepts.

210
Total
210
Cleared
123d
Avg days
1976
Since
210 devices
25–48 of 210
Cleared Aug 29, 2005
PVC AND SILICONE MANUAL RESUSCITATORS
K051177
David Medical Products Co.,Ltd
Anesthesiology · 115d
Cleared Mar 11, 2005
SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,
K042556
Enter Medical Corporation
Anesthesiology · 172d
Cleared Nov 15, 2004
AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR
K042682
Ambu, Inc.
Anesthesiology · 47d
Cleared Nov 12, 2004
AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS
K042843
Ambu, Inc.
Anesthesiology · 29d
Cleared Aug 05, 2004
STURDY MANUAL RESUSCITATOR
K032596
Sturdy Industrial Co., Ltd.
Anesthesiology · 349d
Cleared Jul 16, 2004
MERLIN RESUSCITATOR
K031395
Merlin Medical Limited
Anesthesiology · 441d
Cleared Feb 06, 2004
BAWMED E-Z BAG RESUSCITATOR
K031434
Bawmed UK
Anesthesiology · 276d
Cleared Jan 30, 2004
VADI MANUAL RESUSCITATOR
K030864
Vedi Corp.
Anesthesiology · 318d
Cleared Jun 26, 2003
SMART BAG MO
K021328
O-Two Systems International, Inc.
Anesthesiology · 426d
Cleared Feb 11, 2003
1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR
K023793
Portex, Inc.
Anesthesiology · 90d
Cleared Feb 07, 2003
NELLCOR INDGO MANUAL RESUSCITATOR
K023494
Nellcor Puritan Bennett, Inc.
Anesthesiology · 112d
Cleared Oct 11, 2002
OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR
K021446
Oemedic International, Inc.
Anesthesiology · 158d
Cleared Oct 08, 2002
SIMPLIFY COMPACT RESUSCITATOR
K021716
Polymed (Xiamen) Plastic Industrial Co., Ltd.
Anesthesiology · 138d
Cleared Oct 04, 2002
ACUTEVENTILATOR
K012271
Impoex International, Ltd.
Anesthesiology · 442d
Cleared Oct 04, 2002
PMX COMPACT RESUCITATOR
K021390
Cheen Houng Ent. Co. , Ltd.
Anesthesiology · 155d
Cleared Oct 01, 2002
PMX DISPOSABLE BAG MASK RESUSCITATOR
K014071
Allied Healthcare Products, Inc.
Anesthesiology · 295d
Cleared Jul 30, 2002
OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIR
K021442
Oemedic International, Inc.
Anesthesiology · 85d
Cleared Feb 27, 2002
1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX
K014115
Portex, Inc.
Anesthesiology · 75d
Cleared Sep 18, 2001
V*CARE MANUAL RESUSCITATOR
K012842
Ventlab Corp.
Anesthesiology · 26d
Cleared Jun 26, 2001
Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02
K003927
Cheen Houng Ent. Co. , Ltd.
Anesthesiology · 188d
Cleared Jun 06, 2001
HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR
K002846
Headstar Medical Products Co., Ltd.
Anesthesiology · 267d
Cleared May 17, 2000
AMBU NEONATE SILICONE RESUSCITATOR
K993278
Ambu, Inc.
Anesthesiology · 230d
Cleared Mar 24, 2000
RUSCH MANUAL RESUSCITATOR BAG
K993194
Rusch, Inc.
Anesthesiology · 183d
Cleared Jan 18, 2000
1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE
K991861
Sims Portex, Inc.
Anesthesiology · 231d