Cleared Traditional

K831856 - BREATHING CIRCUIT BACTERIA FILTER

K831856 is an FDA 510(k) clearance for BREATHING CIRCUIT 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 109-day FDA review.

K831856 · Vital Signs, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K831856

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
Combination Product No
PCCP Authorized No
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.

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 146
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K831856.
RESPIR GARD BACTERIA FILTER
K833269 · Marquest Medical Products, Inc. · Oct 1983
DRYDEN MINI BACTERIA FILTER
K833066 · Dryden Corp. · Oct 1983
RESPIR GARD-II OXYGARD HYDROGARD-SPIRO
K833267 · Marquest Medical Products, Inc. · Oct 1983
BREATHING FILTER
K830618 · Ohio Medical Products · Apr 1983
NON-REUSABLE UNIVERSAL NEBULIZER FILTE
K823257 · Ohio Medical Products · Dec 1982
6-435 FILTER PAD, 5/PKG.
K802914 · Lifecare Services, Inc. · Dec 1980