Cleared Traditional

K853238 - APL MUELLER HINTON AGAR

K853238 is an FDA 510(k) clearance for APL MUELLER HINTON AGAR, manufactured by Apl Medical Supplies. The device is a Class 2 Microbiology device with product code JTZ cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K853238 · Apl Medical Supplies · Microbiology device
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Aug 1985
Decision
18d
Days
Class 2
Risk

K853238 is an FDA 510(k) clearance for the APL MUELLER HINTON AGAR. Classified as Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (product code JTZ), Class II - Special 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 866.1700 - 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

FDA 510(k) Submission Details - K853238

510(k) Number K853238 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 102d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JTZ Device Classification - Class 2, Special Controls

Product Code JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1700
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 Microbiology devices follow this clearance model.

Regulatory Peers - JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth

All 44
Devices cleared under the same product code (JTZ) and FDA review panel - the closest regulatory comparables to K853238.
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
K864247 · Mds Laboratories, Inc. · Mar 1987
MUELLER HINTON AGAR - SUPPLEMENTED
K864248 · Mds Laboratories, Inc. · Mar 1987
MUELLER HINTON AGAR W/4%NACL AND OXACILLIN
K863821 · Gibco Laboratories Life Technologies, Inc. · Oct 1986
MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS
K850291 · Remel Co. · May 1985
MUELLER HINTON AGAR & MUELLER HINTON AGAR W/5% SHE
K851589 · Preferred Micro-Media · Apr 1985
MUELLER HINTON CHOCOLATE AGAR
K850843 · Micro Media Laboratories · Mar 1985