Cleared Traditional

K911427 - BREATHING FILTERS

K911427 is an FDA 510(k) clearance for BREATHING FILTERS, manufactured by Intersurgical, Inc.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K911427 · Intersurgical, Inc. · General Hospital
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Aug 1991
Decision
202d
Days
Class 2
Risk

K911427 is an FDA 510(k) clearance for the BREATHING FILTERS. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Intersurgical, Inc. (Cazenovia, US). The FDA issued a Cleared decision on August 26, 1991 after a review of 202 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 Intersurgical, Inc. devices

FDA 510(k) Submission Details - K911427

510(k) Number K911427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1991
Decision Date August 26, 1991
Days to Decision 202 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 129d · This submission: 202d
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 91
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K911427.
MERIDIAN MEDICAL SYSTEMS BREATHING FILTER
K925217 · Merit Medical Systems, Inc. · Jan 1993
VENTILATOR CIRCUITS
K920885 · Vital Signs, Inc. · Oct 1992
BACTERIA FILTER
K912577 · Vital Signs, Inc. · Apr 1992
BACTERIA FILTER
K904830 · Vital Signs, Inc. · Apr 1991
CHILD SIZE - FILTER FLEX (TM)
K893030 · Life Design Systems, Inc. · Sep 1989
RCI VIRAL/BACTERIAL FILTER
K892230 · Respiratory Care, Inc. · Aug 1989