Cleared Traditional

K853236 - APL TSA WITH 5% SHEEP BLOOD

K853236 is the FDA 510(k) clearance for APL TSA WITH 5% SHEEP BLOOD by Apl Medical Supplies. It is a Class 1 Microbiology device (product code KZI) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K853236 · Apl Medical Supplies · Microbiology device
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Aug 1985
Decision
18d
Days
Class 1
Risk

K853236 is an FDA 510(k) clearance for the APL TSA WITH 5% SHEEP BLOOD. Classified as Culture Media, Enriched (product code KZI), Class I - General Controls.

Submitted by Apl Medical Supplies (Las Vegas, US). The FDA issued a Cleared decision on August 19, 1985 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2330 - the FDA microbiology 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 Apl Medical Supplies devices

Submission Details

510(k) Number K853236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1985
Decision Date August 19, 1985
Days to Decision 18 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 102d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KZI Culture Media, Enriched
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2330
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 - KZI Culture Media, Enriched

All 30
Devices cleared under the same product code (KZI) and FDA review panel - the closest regulatory comparables to K853236.
BIOTIS BORDET GENGOU AGAR
K862390 · Otisville Biotech, Inc. · Jul 1986
BIOTIS COOKED MEAT
K860410 · Otisville Biotech, Inc. · Feb 1986
BCYE (BUFFERED CHARCOAL YEAST EXTRACT) AGAR
K854064 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1985
BIOTIS CDC MODIFIED MCCLUNG-TOABE EGG
K843065 · Otisville Biotech, Inc. · Aug 1984
SELENITE CYSTINE BROTH
K832533 · Otisville Biotech, Inc. · Oct 1983
FILDES ENRICHMENT SOLUTON
K830383 · Gibco Laboratories Life Technologies, Inc. · Mar 1983