Cleared Traditional

K993379 - PALL SUPOR AEF FILTER

K993379 is an FDA 510(k) clearance for PALL SUPOR AEF FILTER, manufactured by Pall Corp.. The device is a Class 2 General Hospital device with product code FPB cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K993379 · Pall Corp. · General Hospital
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Dec 1999
Decision
70d
Days
Class 2
Risk

K993379 is an FDA 510(k) clearance for the PALL SUPOR AEF FILTER. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Pall Corp. (East Hills, US). The FDA issued a Cleared decision on December 16, 1999 after a review of 70 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 Pall Corp. devices

FDA 510(k) Submission Details - K993379

510(k) Number K993379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1999
Decision Date December 16, 1999
Days to Decision 70 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
59d faster than avg
Panel avg: 129d · This submission: 70d
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 71
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K993379.
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
0.2 U BACTERIAL FILTER
K974661 · Sims Deltec, Inc. · Feb 1998
AUTOPRIME
K964283 · Arbor Technologies, Inc. · Jan 1997
PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)
K954331 · Pall Biomedical Products Co. · Jan 1997
40 MICRON BLOOD TRANSFUSION FILTER
K941628 · Douglas Medical Products Corp. · Feb 1995