Cleared Traditional

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

K954331 is an FDA 510(k) clearance for PALL LEA FILTER (LIPID EMULSION FILTER)..., manufactured by Pall Biomedical Products Co.. The device is a Class 2 General Hospital device with 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.

FDA 510(k) Submission Details - K954331

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
Combination Product No
PCCP Authorized No
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.

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 81
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K954331.
PALL SUPOR AEF FILTER
K993379 · Pall Corp. · Dec 1999
0.2 U BACTERIAL FILTER
K974661 · Sims Deltec, Inc. · Feb 1998
AUTOPRIME
K964283 · Arbor Technologies, Inc. · Jan 1997
I.V. FILTER SET
K933523 · Mediziv Medical Products 1987 , Ltd. · May 1995
40 MICRON BLOOD TRANSFUSION FILTER
K941628 · Douglas Medical Products Corp. · Feb 1995
1.2 MICRON AIR ELIMINATING FILTER
K942625 · The Medi-Dose Group · Oct 1994
K954331 · PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)
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