Cleared Traditional

K963053 - 9000 SERIES FILTER & FILTER/HME

K963053 is an FDA 510(k) clearance for 9000 SERIES FILTER & FILTER/HME, manufactured by Enternet Medical, Inc.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K963053 · Enternet Medical, Inc. · General Hospital
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Feb 1997
Decision
199d
Days
Class 2
Risk

K963053 is an FDA 510(k) clearance for the 9000 SERIES FILTER & FILTER/HME. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Enternet Medical, Inc. (Las Vegas, US). The FDA issued a Cleared decision on February 21, 1997 after a review of 199 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.5260 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Enternet Medical, Inc. devices

FDA 510(k) Submission Details - K963053

510(k) Number K963053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1996
Decision Date February 21, 1997
Days to Decision 199 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 129d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAH Device Classification - Class 2, Special Controls

Product Code CAH Filter, Bacterial, Breathing-circuit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5260
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - CAH Filter, Bacterial, Breathing-circuit

All 141
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K963053.
HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)
K964382 · Gibeck, Inc. · Apr 1997
POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER
K965020 · Porous Media Corp. · Mar 1997
POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER
K964979 · Porous Media Corp. · Mar 1997
ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT
K962045 · Mallinckrodt Medical · Nov 1996
ENGSTROM HMEF 1000
K964204 · Datex Engstrom AB · Nov 1996
RESPIRGARD II, SPIROGARD
K961838 · Marquest Medical Products, Inc. · Oct 1996