Cleared Traditional

K965016 - ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)

K965016 is an FDA 510(k) clearance for ISO-GARD FILTER ANGLED(18212)/ISO-GARD ..., manufactured by Gibeck, Inc.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 351-day FDA review.

K965016 · Gibeck, Inc. · General Hospital
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Dec 1997
Decision
351d
Days
Class 2
Risk

K965016 is an FDA 510(k) clearance for the ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212). Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Gibeck, Inc. (Indianapolis, US). The FDA issued a Cleared decision on December 2, 1997 after a review of 351 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Gibeck, Inc. devices

FDA 510(k) Submission Details - K965016

510(k) Number K965016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1996
Decision Date December 02, 1997
Days to Decision 351 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
222d slower than avg
Panel avg: 129d · This submission: 351d
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 K965016.
BREATHING CIRCUIT BACTERIAL FILTER
K973797 · King Systems Corp. · Mar 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
SPIROSAFE FILTER
K973314 · Micro Direct, Inc. · Nov 1997
FILTER
K970102 · Promedic, Inc. · Jun 1997
HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)
K964382 · Gibeck, Inc. · Apr 1997