Cleared Traditional

K800153 - EXTEMP/EXTEMP-V

K800153 is an FDA 510(k) clearance for EXTEMP/EXTEMP-V, manufactured by Pharma-Filter, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAA cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K800153 · Pharma-Filter, Inc. · General & Plastic Surgery device
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Feb 1980
Decision
14d
Days
Class 1
Risk

K800153 is an FDA 510(k) clearance for the EXTEMP/EXTEMP-V. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Pharma-Filter, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 6, 1980 after a review of 14 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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 Pharma-Filter, Inc. devices

FDA 510(k) Submission Details - K800153

510(k) Number K800153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1980
Decision Date February 06, 1980
Days to Decision 14 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 115d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

GAA Device Classification - Class 1, General Controls

Product Code GAA Needle, Aspiration And Injection, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GAA Needle, Aspiration And Injection, Disposable

All 75
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K800153.
ADT PERITONEAL LAVAGE TRAY (DISP.)
K800421 · A.D.T. Lab Industries · Mar 1980
ADT NERVE BLOCK TRAY(DISP.)
K800423 · A.D.T. Lab Industries · Mar 1980
FERRIS BONE MARROW -NEEDLE-(DISPOSABLE)
K800407 · A.D.T. Lab Industries · Mar 1980
BURRON VENTED NEEDLE
K790472 · National Patent Development Corp. · Mar 1979
NEEDLE II, BURRON FILTER
K790060 · National Patent Development Corp. · Mar 1979
NEEDLE, WITH FILTER
K790142 · National Patent Development Corp. · Feb 1979