Cleared Traditional

K951047 - BACTERIAL/VIRAL FILTER PRODUCT NUMBERS ...

K951047 is the FDA 510(k) clearance for BACTERIAL/VIRAL FILTER PRODUCT NUMBERS ... by Vital Signs, Inc.. It is a Class 2 General Hospital device (product code CAH) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K951047 · Vital Signs, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
88d
Days
Class 2
Risk

K951047 is an FDA 510(k) clearance for the BACTERIAL/VIRAL FILTER PRODUCT NUMBERS 5100FILT, 5100THINM, 5100HEPA. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Vital Signs, Inc. (Totowa, US). The FDA issued a Cleared decision on June 2, 1995 after a review of 88 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 Vital Signs, Inc. devices

Submission Details

510(k) Number K951047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1995
Decision Date June 02, 1995
Days to Decision 88 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
41d faster than avg
Panel avg: 129d · This submission: 88d
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 73
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K951047.
ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT
K962045 · Mallinckrodt Medical · Nov 1996
RESPIRGARD II, SPIROGARD
K961838 · Marquest Medical Products, Inc. · Oct 1996
PFT FILTER
K952062 · Intertech Resources, Inc. · Jun 1995
SPIROBAC ADAPTERS
K944124 · Mallinckrodt Medical · Sep 1994
STERIVENT AND STERIVENT S
K941676 · Mallinckrodt Medical · May 1994
BARRIERBAC AND BARRIERBAC S
K941536 · Mallinckrodt Medical · Apr 1994