Cleared Traditional

K931290 - REMEL CEFMETAZOLE 30 MCG SUSCEPTIBILITY...

K931290 is the FDA 510(k) clearance for REMEL CEFMETAZOLE 30 MCG SUSCEPTIBILITY... by Remel Co.. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K931290 · Remel Co. · Microbiology device
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May 1993
Decision
69d
Days
Class 2
Risk

K931290 is an FDA 510(k) clearance for the REMEL CEFMETAZOLE 30 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 May 20, 1993 after a review of 69 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 K931290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1993
Decision Date May 20, 1993
Days to Decision 69 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
33d faster than avg
Panel avg: 102d · This submission: 69d
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 K931290.
REMEL CLARITHROMYCIN 15 MCG SUSCEPTIBILITY DISK
K933118 · Remel Co. · Aug 1993
REMEL LORACARBEF 30 MCG SUSCEPTIBILITY DISK
K931799 · Remel Co. · Jun 1993
REMEL CEFPODOXIME 10 MCG SUSCEPTIBILITY DISK
K931289 · Remel Co. · Jun 1993
BILE SPOT REAGENT
K931530 · Hardy Diagnostics · May 1993
DISPENS-O-DISC CLARITHROMYCIN 15 MG.
K930911 · Difco Laboratories, Inc. · Apr 1993
DISPENS-O-DISC CEFPODOXIME 10 MCG.
K930946 · Difco Laboratories, Inc. · Apr 1993