Cleared Traditional

K953687 - WESTMED PEDIATRIC BACTERIAL/VIRAL FILTER

K953687 is an FDA 510(k) clearance for WESTMED PEDIATRIC BACTERIAL/VIRAL FILTER, manufactured by Westmed Intl.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K953687 · Westmed Intl. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
42d
Days
Class 2
Risk

K953687 is an FDA 510(k) clearance for the WESTMED PEDIATRIC BACTERIAL/VIRAL FILTER. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Westmed Intl. (Tucson, US). The FDA issued a Cleared decision on September 18, 1995 after a review of 42 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.

View all Westmed Intl. devices

FDA 510(k) Submission Details - K953687

510(k) Number K953687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1995
Decision Date September 18, 1995
Days to Decision 42 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
87d faster than avg
Panel avg: 129d · This submission: 42d
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 134
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K953687.
MERCURY MEDICAL CPR BAG EXHALATION FILTER
K954490 · Mercury Medical · Oct 1996
BACTERIA/VIRAL FILTER
K961914 · Hudson Respiratory Care, Inc. · Aug 1996
ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT
K954828 · Gibeck, Inc. · May 1996
PFT FILTER
K952062 · Intertech Resources, Inc. · Jun 1995
BACTERIAL/VIRAL FILTER PRODUCT NUMBERS 5100FILT, 5100THINM, 5100HEPA
K951047 · Vital Signs, Inc. · Jun 1995
PRIMA FILTER
K952015 · Prima, Inc. · May 1995