Cleared Traditional

K924765 - REMEL LOMEFLOXACIN 10 MCG SUSCEPTIBILIT...

K924765 is the FDA 510(k) clearance for REMEL LOMEFLOXACIN 10 MCG SUSCEPTIBILIT... by Remel Co.. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K924765 · Remel Co. · Microbiology device
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Oct 1992
Decision
33d
Days
Class 2
Risk

K924765 is an FDA 510(k) clearance for the REMEL LOMEFLOXACIN 10 MCG SUSCEPTIBILITY DISK. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on October 26, 1992 after a review of 33 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 Remel Co. devices

Submission Details

510(k) Number K924765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1992
Decision Date October 26, 1992
Days to Decision 33 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 102d · This submission: 33d
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 282
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K924765.
REMEL ENOXACIN 10 MCG SUSCEPTIBILITY DISK
K925060 · Remel Co. · Dec 1992
REMEL CEFACLOR 30MCG SUSCEPTIBILITY DISK
K924846 · Remel Co. · Nov 1992
CEFPODOXIME 10 MCG, SENSI DISC
K924797 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1992
REMEL OFLOXACIN 5MCG SUSCEPTIBILITY DISK
K924766 · Remel Co. · Oct 1992
LORACARBEF 30MCG DISK
K922791 · Difco Laboratories, Inc. · Jul 1992
CEFZIL
K922793 · Difco Laboratories, Inc. · Jul 1992