Cleared Traditional

K961188 - CEFEPIME

K961188 is the FDA 510(k) clearance for CEFEPIME by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K961188 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
10d
Days
Class 2
Risk

K961188 is an FDA 510(k) clearance for the CEFEPIME, 30 MCG, SENSI-DISC. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Cockeysville, US). The FDA issued a Cleared decision on April 5, 1996 after a review of 10 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K961188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1996
Decision Date April 05, 1996
Days to Decision 10 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 102d · This submission: 10d
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 294
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K961188.
CETIBUTEN, 30MCG, SENSI-DISC
K965159 · Becton Dickinson Microbiology Systems · Feb 1997
MEROPENEM, 10 MCG, SENSI-DISC
K963845 · Becton Dickinson Microbiology Systems · Oct 1996
DISPENS-O-DISC MEROPENEM
K963508 · Difco Laboratories, Inc. · Sep 1996
REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK
K955669 · Remel Co. · Feb 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