Cleared Traditional

K961914 - BACTERIA/VIRAL FILTER

K961914 is an FDA 510(k) clearance for BACTERIA/VIRAL FILTER, manufactured by Hudson Respiratory Care, Inc.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K961914 · Hudson Respiratory Care, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
89d
Days
Class 2
Risk

K961914 is an FDA 510(k) clearance for the BACTERIA/VIRAL FILTER. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Hudson Respiratory Care, Inc. (Temecula, US). The FDA issued a Cleared decision on August 14, 1996 after a review of 89 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K961914

510(k) Number K961914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1996
Decision Date August 14, 1996
Days to Decision 89 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 129d · This submission: 89d
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 185
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K961914.
ENGSTROM HMEF 1000
K964204 · Datex Engstrom AB · Nov 1996
RESPIRGARD II, SPIROGARD
K961838 · Marquest Medical Products, Inc. · Oct 1996
MERCURY MEDICAL CPR BAG EXHALATION FILTER
K954490 · Mercury Medical · Oct 1996
ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT
K954828 · Gibeck, Inc. · May 1996
WESTMED PEDIATRIC BACTERIAL/VIRAL FILTER
K953687 · Westmed Intl. · Sep 1995
POROUS MEDIA DBF23-R REUSABLE RESPIRATORY FILTER
K952428 · Porous Media Corp. · Jul 1995
K961914 · BACTERIA/VIRAL FILTER
Download PDF FDA Summary Hudson Respiratory Ca…