Cleared Traditional

K853610 - APL MOTILITY INDOLE ORNITHINE AGAR

K853610 is the FDA 510(k) clearance for APL MOTILITY INDOLE ORNITHINE AGAR by Apl Medical Supplies. It is a Class 1 Microbiology device (product code JSH) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K853610 · Apl Medical Supplies · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1985
Decision
18d
Days
Class 1
Risk

K853610 is an FDA 510(k) clearance for the APL MOTILITY INDOLE ORNITHINE AGAR. Classified as Culture Media, Non-selective And Differential (product code JSH), Class I - General Controls.

Submitted by Apl Medical Supplies (Las Vegas, US). The FDA issued a Cleared decision on September 16, 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 866.2320 - 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 K853610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1985
Decision Date September 16, 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 JSH Culture Media, Non-selective And Differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2320
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 - JSH Culture Media, Non-selective And Differential

All 102
Devices cleared under the same product code (JSH) and FDA review panel - the closest regulatory comparables to K853610.
BIOTIS HAEMOPHILUS IDENTIFICATION QUAD
K862387 · Otisville Biotech, Inc. · Jul 1986
BIOTIS DECARBOXYLASE MEDIA, BASE
K862395 · Otisville Biotech, Inc. · Jul 1986
PSEUDOMONAS AGAR P (MEDIUM A)
K860750 · Gibco Laboratories Life Technologies, Inc. · Mar 1986
DNASE W/TOLUIDINE BLUE, DNASE W/INDICATOR
K853336 · Hardy Media · Aug 1985
CLED AGAR
K852578 · American Laboratory Supply, Inc. · Jul 1985
DRI-FORM PSEUDOMONAS AGAR F
K852064 · Gibco Laboratories Life Technologies, Inc. · Jun 1985