Cleared Traditional

K934189 - BARRIERFLEX-I, AND BARRIERFLES-II

K934189 is an FDA 510(k) clearance for BARRIERFLEX-I, manufactured by Bird Life Design. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K934189 · Bird Life Design · General Hospital
Download Printable Device Report (PDF)
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Nov 1993
Decision
90d
Days
Class 2
Risk

K934189 is an FDA 510(k) clearance for the BARRIERFLEX-I, AND BARRIERFLES-II. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Bird Life Design (Dallas, US). The FDA issued a Cleared decision on November 24, 1993 after a review of 90 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 Bird Life Design devices

FDA 510(k) Submission Details - K934189

510(k) Number K934189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1993
Decision Date November 24, 1993
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
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 149
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K934189.
STERIVENT AND STERIVENT S
K941676 · Mallinckrodt Medical · May 1994
BARRIERBAC AND BARRIERBAC S
K941536 · Mallinckrodt Medical · Apr 1994
HYGROBAC,S HYGROBOY AND HYGROBABY
K941381 · Mallinckrodt Medical · Apr 1994
SENSORMEDICS MICROGARD MICROBIAL FILTER
K934272 · Sensor Medics Corp. · Nov 1993
HEPA FILTERED HME
K930816 · Intertech Resources, Inc. · Jul 1993
BREATHING FILTERS 1942T/1941T/2014T
K925462 · Intersurgical, Inc. · May 1993