Cleared Traditional

K973797 - BREATHING CIRCUIT BACTERIAL FILTER

K973797 is an FDA 510(k) clearance for BREATHING CIRCUIT BACTERIAL FILTER, manufactured by King Systems Corp.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K973797 · King Systems Corp. · General Hospital
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Mar 1998
Decision
157d
Days
Class 2
Risk

K973797 is an FDA 510(k) clearance for the BREATHING CIRCUIT BACTERIAL FILTER. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by King Systems Corp. (Noblesville, US). The FDA issued a Cleared decision on March 12, 1998 after a review of 157 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.

FDA 510(k) Submission Details - K973797

510(k) Number K973797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1997
Decision Date March 12, 1998
Days to Decision 157 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
28d slower than avg
Panel avg: 129d · This submission: 157d
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 176
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K973797.
LICHEN, BACTERIAL IN LINE BREATHING FILTER
K980662 · Dhd Healthcare Corp. · Sep 1998
CIRCUIT GUARD
K982239 · Arc Medical, Inc. · Aug 1998
POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER
K982127 · Porous Media Corp. · Jun 1998
ZEFON ADULT ANESTHESIA BREATHING CIRCUIT WITH FILTER, ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT WITH FILTER
K973238 · Bill Olson Corp. · Mar 1998
72 HOUR USE TRACH CARE WITH MICROBAN
K974630 · Ballard Medical Products · Mar 1998
ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)
K965016 · Gibeck, Inc. · Dec 1997
K973797 · BREATHING CIRCUIT BACTERIAL FILTER
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