Cleared Traditional

BREATHING CIRCUIT BACTERIA FILTER (K831856) - FDA 510(k) Clearance

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

K831856 · Vital Signs, Inc. · General Hospital
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Sep 1983
Decision
109d
Days
Class 2
Risk

K831856 is an FDA 510(k) clearance for the BREATHING CIRCUIT BACTERIA FILTER. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Vital Signs, Inc. (East Rutherford, US). The FDA issued a Cleared decision on September 26, 1983 after a review of 109 days - within the typical 510(k) review window.

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 Vital Signs, Inc. devices

Submission Details

510(k) Number K831856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1983
Decision Date September 26, 1983
Days to Decision 109 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
20d faster than avg
Panel avg: 129d · This submission: 109d
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 19
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K831856.
Servo Guard
K182862 · Maquet Critical Care AB · Oct 2019
SafeBreath Filter Mouthpiece
K190022 · MD Diagnostics Limited · Sep 2019
MERIDIAN MEDICAL SYSTEMS BREATHING FILTER
K925217 · Merit Medical Systems, Inc. · Jan 1993
3M BRAND ANESTHESIA FILTER,#3110
K760611 · 3M Company · Sep 1976
FILTER, RESPIRATORY (U-MID)
K760041 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1976