Cleared Traditional

K912577 - BACTERIA FILTER

K912577 is an FDA 510(k) clearance for BACTERIA FILTER, manufactured by Vital Signs, Inc.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K912577 · Vital Signs, Inc. · General Hospital
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Apr 1992
Decision
315d
Days
Class 2
Risk

K912577 is an FDA 510(k) clearance for the BACTERIA FILTER. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Vital Signs, Inc. (Totowa, US). The FDA issued a Cleared decision on April 22, 1992 after a review of 315 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 Vital Signs, Inc. devices

FDA 510(k) Submission Details - K912577

510(k) Number K912577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1991
Decision Date April 22, 1992
Days to Decision 315 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
186d slower than avg
Panel avg: 129d · This submission: 315d
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 145
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K912577.
MED-PLASTICS INTL., INC. BREATHING FILTER
K930760 · Med-Plastics Intl., Inc. · Mar 1993
MERIDIAN MEDICAL SYSTEMS BREATHING FILTER
K925217 · Merit Medical Systems, Inc. · Jan 1993
VENTILATOR CIRCUITS
K920885 · Vital Signs, Inc. · Oct 1992
BREATHING FILTERS
K911427 · Intersurgical, Inc. · Aug 1991
BACTERIA FILTER
K904830 · Vital Signs, Inc. · Apr 1991
CHILD SIZE - FILTER FLEX (TM)
K893030 · Life Design Systems, Inc. · Sep 1989