Cleared Traditional

K932301 - FENWAL(R) 40/150 MICRON DUAL SCREEN FILTER

K932301 is an FDA 510(k) clearance for FENWAL 40/150 MICRON DUAL SCREEN FILTER, manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code FPB cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K932301 · Baxter Healthcare Corp · General Hospital
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Nov 1993
Decision
182d
Days
Class 2
Risk

K932301 is an FDA 510(k) clearance for the FENWAL(R) 40/150 MICRON DUAL SCREEN FILTER. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on November 10, 1993 after a review of 182 days - an extended review 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: 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K932301

510(k) Number K932301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1993
Decision Date November 10, 1993
Days to Decision 182 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 129d · This submission: 182d
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 K932301.
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
MIS CLEAN-SET FLUSHING UNIT AND ACCESSORIES
K933294 · Aesculap, Inc. · Feb 1994
FENWAL 40 MICRON TRANSFUSION FILTER
K931441 · Baxter Healthcare Corp · Sep 1993
IVEX-HP96 EXTENDED LIFE FILTER SET
K920736 · Abbott Laboratories · Apr 1993
IVEX-TPN EXTENSION FILTER SET
K913308 · Abbott Laboratories · Jan 1992