Cleared Traditional

K912577 - BACTERIA FILTER (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
187d slower than avg
Panel avg: 128d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 200
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K912577.
Ambu® Virobac II® Exhalation Filter
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Besmed Bacterial Filter and HMEF
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Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
K230483 · Passy-Muir, Inc. · Sep 2023
TNI Clear-Guard™ 3 angled breathing filter (1545020)
K223258 · Intersurgical , Ltd. · Jun 2023
Filter and HME/Filter
K221472 · Ningbo Huakun Medical Equipment Co., Ltd. · Feb 2023