Cleared Traditional

K933869 - EXTENSION SET WITH 0.22 MICRON 96 HOUR ...

K933869 is the FDA 510(k) clearance for EXTENSION SET WITH 0.22 MICRON 96 HOUR ... by Baxter Healthcare Corp. It is a Class 2 General Hospital device (product code FPB) cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K933869 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
260d
Days
Class 2
Risk

K933869 is an FDA 510(k) clearance for the EXTENSION SET WITH 0.22 MICRON 96 HOUR 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 April 26, 1994 after a review of 260 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

Submission Details

510(k) Number K933869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1993
Decision Date April 26, 1994
Days to Decision 260 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
131d slower than avg
Panel avg: 129d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 45
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K933869.
PHARMASSURE LARGE VOLUME TRANSFER FILTERS
K943127 · Gelman Sciences, Inc. · Sep 1994
IVEX-2 EXTENSION SET WITH Y-INJECTION SITE
K941684 · Abbott Laboratories · Aug 1994
VIAL VENT FILTER
K942275 · Gelman Sciences, Inc. · Jul 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