Cleared Traditional

K954331 - PALL LEA FILTER (LIPID EMULSION FILTER)...

K954331 is the FDA 510(k) clearance for PALL LEA FILTER (LIPID EMULSION FILTER)... by Pall Biomedical Products Co.. It is a Class 2 General Hospital device (product code FPB) cleared through the Traditional 510(k) pathway after a 482-day FDA review.

K954331 · Pall Biomedical Products Co. · General Hospital
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Jan 1997
Decision
482d
Days
Class 2
Risk

K954331 is an FDA 510(k) clearance for the PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER). Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Pall Biomedical Products Co. (East Hills, US). The FDA issued a Cleared decision on January 9, 1997 after a review of 482 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Pall Biomedical Products Co. devices

Submission Details

510(k) Number K954331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1995
Decision Date January 09, 1997
Days to Decision 482 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
353d slower than avg
Panel avg: 129d · This submission: 482d
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 28
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K954331.
Filter Needle for Single Use
K233277 · Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · May 2024
NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER
K113227 · Baxter Healthcare Corp · Dec 2011
IVEX-2 EXTENSION SET WITH Y-INJECTION SITE
K941684 · Abbott Laboratories · Aug 1994
EXTENSION SET WITH 0.22 MICRON 96 HOUR FILTER
K933869 · Baxter Healthcare Corp · Apr 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