Cleared Traditional

K942275 - VIAL VENT FILTER

K942275 is an FDA 510(k) clearance for VIAL VENT FILTER, manufactured by Gelman Sciences, Inc.. The device is a Class 2 General Hospital device with product code FPB cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K942275 · Gelman Sciences, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
77d
Days
Class 2
Risk

K942275 is an FDA 510(k) clearance for the VIAL VENT FILTER. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Gelman Sciences, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on July 26, 1994 after a review of 77 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Gelman Sciences, Inc. devices

FDA 510(k) Submission Details - K942275

510(k) Number K942275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1994
Decision Date July 26, 1994
Days to Decision 77 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
52d faster than avg
Panel avg: 129d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPB Device Classification - Class 2, Special Controls

Product Code FPB Filter, Infusion Line
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPB Filter, Infusion Line

All 72
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K942275.
40 MICRON BLOOD TRANSFUSION FILTER
K941628 · Douglas Medical Products Corp. · Feb 1995
PHARMASSURE LARGE VOLUME TRANSFER FILTERS
K943127 · Gelman Sciences, Inc. · Sep 1994
IVEX-2 EXTENSION SET WITH Y-INJECTION SITE
K941684 · Abbott Laboratories · Aug 1994
CHARGED SUPOR(R) FILTER EXTENSION SET
K940980 · B. Braun of America, Inc. · Jul 1994
EXTENSION SET WITH 0.22 MICRON 96 HOUR FILTER
K933869 · Baxter Healthcare Corp · Apr 1994
1.2 MICRON FINAL FILTER WITH EXTENSION TUBE
K940293 · Puritas Health Care, Inc. · Mar 1994