Cleared Traditional

K973238 - ZEFON ADULT ANESTHESIA BREATHING CIRCUIT WITH FILTER, ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT WITH FILTER

K973238 is an FDA 510(k) clearance for ZEFON ADULT ANESTHESIA BREATHING CIRCUI..., manufactured by Bill Olson Corp.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K973238 · Bill Olson Corp. · General Hospital
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Optimized for regulatory review, auditing and printing
Mar 1998
Decision
195d
Days
Class 2
Risk

K973238 is an FDA 510(k) clearance for the ZEFON ADULT ANESTHESIA BREATHING CIRCUIT WITH FILTER, ZEFON PEDIATRIC ANESTHE.... Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Bill Olson Corp. (Ocala, US). The FDA issued a Cleared decision on March 11, 1998 after a review of 195 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 Bill Olson Corp. devices

FDA 510(k) Submission Details - K973238

510(k) Number K973238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1997
Decision Date March 11, 1998
Days to Decision 195 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
66d slower than avg
Panel avg: 129d · This submission: 195d
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 114
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K973238.
CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18
K983610 · Intersurgical, Inc. · Apr 1999
BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F)
K983817 · King Systems Corp. · Mar 1999
BREATHING CIRCUIT BACTERIAL FILTER
K973797 · King Systems 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
SPIROSAFE FILTER
K973314 · Micro Direct, Inc. · Nov 1997