Cleared Traditional

K955669 - REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK

K955669 is an FDA 510(k) clearance for REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK, manufactured by Remel Co.. The device is a Class 2 Microbiology device with product code JTN cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K955669 · Remel Co. · Microbiology device
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Feb 1996
Decision
72d
Days
Class 2
Risk

K955669 is an FDA 510(k) clearance for the REMEL CEFEPIME 30 UG 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 February 23, 1996 after a review of 72 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

FDA 510(k) Submission Details - K955669

510(k) Number K955669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1995
Decision Date February 23, 1996
Days to Decision 72 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
30d faster than avg
Panel avg: 102d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JTN Device Classification - Class 2, Special Controls

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 323
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K955669.
GENTAMICIN DISK (120MCG)
K961818 · Remel, L.P. · Jul 1996
STREPTOMYCIN DISK (300MCG)
K961819 · Remel, L.P. · Jul 1996
CEFEPIME, 30 MCG, SENSI-DISC
K961188 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1996
DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG.
K944275 · Difco Laboratories, Inc. · Dec 1994
GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBILITY TESTS
K943407 · Becton Dickinson Microbiology Systems · Oct 1994
REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG
K935975 · Remel, Inc. · Sep 1994