CAH · Class II · 21 CFR 868.5260

FDA Product Code CAH: Filter, Bacterial, Breathing-circuit

Leading manufacturers include Intersurgical, Inc., Medipart Jerry Alexander and Vital Signs, Inc..

202
Total
202
Cleared
127d
Avg days
1976
Since
202 devices
73–96 of 202
Cleared Nov 26, 1996
ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT
K962045
Mallinckrodt Medical
General Hospital · 182d
Cleared Nov 13, 1996
ENGSTROM HMEF 1000
K964204
Datex Engstrom AB
General Hospital · 76d
Cleared Oct 18, 1996
RESPIRGARD II, SPIROGARD
K961838
Marquest Medical Products, Inc.
General Hospital · 158d
Cleared Oct 03, 1996
MERCURY MEDICAL CPR BAG EXHALATION FILTER
K954490
Mercury Medical
General Hospital · 372d
Cleared Aug 14, 1996
BACTERIA/VIRAL FILTER
K961914
Hudson Respiratory Care, Inc.
General Hospital · 89d
Cleared May 02, 1996
ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT
K954828
Gibeck, Inc.
General Hospital · 195d
Cleared Jun 08, 1995
PFT FILTER
K952062
Intertech Resources, Inc.
General Hospital · 37d
Cleared Jun 02, 1995
BACTERIAL/VIRAL FILTER PRODUCT NUMBERS 5100FILT, 5100THINM, 5100HEPA
K951047
Vital Signs, Inc.
General Hospital · 88d
Cleared May 22, 1995
PRIMA FILTER
K952015
Prima, Inc.
General Hospital · 24d
Cleared Nov 30, 1994
DISPOSABLE BACTERIAL BREATHNG FILTER
K915750
Hospitak, Inc.
General Hospital · 1077d
Cleared Sep 08, 1994
SPIROBAC ADAPTERS
K944124
Mallinckrodt Medical
General Hospital · 16d
Cleared May 20, 1994
STERIVENT AND STERIVENT S
K941676
Mallinckrodt Medical
General Hospital · 45d
Cleared Apr 19, 1994
BARRIERBAC AND BARRIERBAC S
K941536
Mallinckrodt Medical
General Hospital · 20d
Cleared Apr 15, 1994
HYGROBAC,S HYGROBOY AND HYGROBABY
K941381
Mallinckrodt Medical
General Hospital · 24d
Cleared Nov 24, 1993
SENSORMEDICS MICROGARD MICROBIAL FILTER
K934272
Sensor Medics Corp.
General Hospital · 85d
Cleared Jul 01, 1993
HEPA FILTERED HME
K930816
Intertech Resources, Inc.
General Hospital · 134d
Cleared May 21, 1993
BREATHING FILTERS 1942T/1941T/2014T
K925462
Intersurgical, Inc.
General Hospital · 204d
Cleared May 19, 1993
BREATHING FILTER
K931842
Mag, Inc.
General Hospital · 36d
Cleared May 11, 1993
LIFE SHIELD HEALTHCARE PRODUCTS BREATHING FILTER
K925388
Life Shield Healthcare Products, Inc.
General Hospital · 197d
Cleared Mar 11, 1993
MED-PLASTICS INTL., INC. BREATHING FILTER
K930760
Med-Plastics Intl., Inc.
General Hospital · 27d
Cleared Jan 26, 1993
MERIDIAN MEDICAL SYSTEMS BREATHING FILTER
K925217
Merit Medical Systems, Inc.
General Hospital · 102d
Cleared Oct 23, 1992
VENTILATOR CIRCUITS
K920885
Vital Signs, Inc.
General Hospital · 262d
Cleared Apr 22, 1992
BACTERIA FILTER
K912577
Vital Signs, Inc.
General Hospital · 315d
Cleared Aug 26, 1991
BREATHING FILTERS
K911427
Intersurgical, Inc.
General Hospital · 202d