Cleared Traditional

K792021 - LARGE VOLUME 5 MICRON CONICAL FILTER

K792021 is an FDA 510(k) clearance for LARGE VOLUME 5 MICRON CONICAL FILTER, manufactured by National Patent Development Corp.. The device is a Class 2 General Hospital device with product code FPB cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K792021 · National Patent Development Corp. · General Hospital
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Oct 1979
Decision
17d
Days
Class 2
Risk

K792021 is an FDA 510(k) clearance for the LARGE VOLUME 5 MICRON CONICAL FILTER. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by National Patent Development Corp. (Mchenry, US). The FDA issued a Cleared decision on October 26, 1979 after a review of 17 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 National Patent Development Corp. devices

FDA 510(k) Submission Details - K792021

510(k) Number K792021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1979
Decision Date October 26, 1979
Days to Decision 17 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 129d · This submission: 17d
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 65
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K792021.
B-D FILTER NEEDLE
K801343 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1980
MICROBAR MONITORING LINE FILTER
K792510 · Medex, Inc. · Dec 1979
BIOGUARD INFUSION LINE FILTER
K791822 · United States Surgical, A Division of Tyco Healthc · Nov 1979
ULTIPOR SOLUTION CONTAINER FILTER
K790879 · Pall Biomedical Products Co. · Jun 1979
JELCO* DISC FILTER-0.2 MICRON
K790471 · Jelco Laboratories · Apr 1979
FLUID ADMINISTRATION SETS, 15 MICRON
K790314 · Medex, Inc. · Mar 1979