Cleared Traditional

ANTIMICROBIAL SUSCEPTIBILITY DISK (K895392) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K895392 · Organon Teknika Corp. · Microbiology device
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Oct 1989
Decision
49d
Days
Class 2
Risk

K895392 is an FDA 510(k) clearance for the ANTIMICROBIAL SUSCEPTIBILITY DISK. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on October 24, 1989 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1620 - 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 Organon Teknika Corp. devices

Submission Details

510(k) Number K895392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1989
Decision Date October 24, 1989
Days to Decision 49 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
53d faster than avg
Panel avg: 102d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JTN Susceptibility Test Discs, Antimicrobial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1620
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 - JTN Susceptibility Test Discs, Antimicrobial

All 99
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K895392.
OFLOXACIN, 5 MCG SENSI-DISC
K910506 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1991
CEFIXIME 5 MCG SUSCEPTIBILITY DISK
K900344 · Organon Teknika Corp. · Feb 1990
CEFMATZOLE 30 MCG SENSI DISC
K895679 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1990
SPECTINOMYCIN 100 MCG SENSI-DISC
K891772 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1989
CEFIXIME, 5 MCG SENSI-DISC ANTIMIC SUSCEP TEST DIS
K893754 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1989
AMPICILLIN/SULBACTAM 10/10 MCG SUSCEPTIBILITY DISK
K874256 · Organon Teknika Corp. · Nov 1987