Cleared Traditional

K943127 - PHARMASSURE LARGE VOLUME TRANSFER FILTERS

K943127 is an FDA 510(k) clearance for PHARMASSURE LARGE VOLUME TRANSFER FILTERS, 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 92-day FDA review.

K943127 · Gelman Sciences, Inc. · General Hospital
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Sep 1994
Decision
92d
Days
Class 2
Risk

K943127 is an FDA 510(k) clearance for the PHARMASSURE LARGE VOLUME TRANSFER FILTERS. 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 September 29, 1994 after a review of 92 days - within the typical 510(k) review window.

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: 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 Gelman Sciences, Inc. devices

FDA 510(k) Submission Details - K943127

510(k) Number K943127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1994
Decision Date September 29, 1994
Days to Decision 92 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
37d faster than avg
Panel avg: 129d · This submission: 92d
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 K943127.
AUTOPRIME
K964283 · Arbor Technologies, Inc. · Jan 1997
PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)
K954331 · Pall Biomedical Products Co. · Jan 1997
40 MICRON BLOOD TRANSFUSION FILTER
K941628 · Douglas Medical Products Corp. · Feb 1995
IVEX-2 EXTENSION SET WITH Y-INJECTION SITE
K941684 · Abbott Laboratories · Aug 1994
VIAL VENT FILTER
K942275 · Gelman Sciences, Inc. · Jul 1994
CHARGED SUPOR(R) FILTER EXTENSION SET
K940980 · B. Braun of America, Inc. · Jul 1994