Cleared Traditional

IVEX-TPN EXTENSION FILTER SET (K913308) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K913308 · Abbott Laboratories · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
174d
Days
Class 2
Risk

K913308 is an FDA 510(k) clearance for the IVEX-TPN EXTENSION FILTER SET. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on January 15, 1992 after a review of 174 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 Abbott Laboratories devices

Submission Details

510(k) Number K913308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1991
Decision Date January 15, 1992
Days to Decision 174 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
45d slower than avg
Panel avg: 129d · This submission: 174d
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 25
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K913308.
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
LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER
K880605 · Miles Laboratories, Inc. · May 1988
CUTTER PUREFLO PLUS IV FILTER
K872634 · Miles Laboratories, Inc. · Aug 1987
CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER
K865029 · Travenol Laboratories, S.A. · Apr 1987