Cleared Traditional

K935641 - 0.2. MICRON FILTER SETS AND 1.2 MICRON FILTER SETS

K935641 is an FDA 510(k) clearance for 0.2. MICRON FILTER SETS AND 1.2 MICRON ..., manufactured by Evans Medical, Inc.. The device is a Class 2 General Hospital device with product code FPB cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K935641 · Evans Medical, Inc. · General Hospital
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Jan 1994
Decision
67d
Days
Class 2
Risk

K935641 is an FDA 510(k) clearance for the 0.2. MICRON FILTER SETS AND 1.2 MICRON FILTER SETS. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Evans Medical, Inc. (Pineville, US). The FDA issued a Cleared decision on January 28, 1994 after a review of 67 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 Evans Medical, Inc. devices

FDA 510(k) Submission Details - K935641

510(k) Number K935641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1993
Decision Date January 28, 1994
Days to Decision 67 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 129d · This submission: 67d
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 73
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K935641.
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(R) 40/150 MICRON DUAL SCREEN FILTER
K932301 · Baxter Healthcare Corp · Nov 1993
FENWAL 40 MICRON TRANSFUSION FILTER
K931441 · Baxter Healthcare Corp · Sep 1993
IVEX-HP96 EXTENDED LIFE FILTER SET
K920736 · Abbott Laboratories · Apr 1993