Cleared Traditional

K860536 - CEFOTETAN 30 MCG SENSI DISC

K860536 is the FDA 510(k) clearance for CEFOTETAN 30 MCG SENSI DISC 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 19-day FDA review.

K860536 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Mar 1986
Decision
19d
Days
Class 2
Risk

K860536 is an FDA 510(k) clearance for the CEFOTETAN 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 (Paramus, US). The FDA issued a Cleared decision on March 3, 1986 after a review of 19 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 K860536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1986
Decision Date March 03, 1986
Days to Decision 19 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
83d faster than avg
Panel avg: 102d · This submission: 19d
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 K860536.
CEFOTETAN 30 MCG ANTIMICROBIAL SUSCEPTIBILITY DISK
K860895 · Organon Teknika Corp. · Apr 1986
OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS
K860153 · Oxoid U.S.A., Inc. · Mar 1986
CEFOTETAN 30 MCG SENSITIVITY DISCS
K860527 · Difco Laboratories, Inc. · Mar 1986
CEFACLOR 30 MCG SENSITIVITY DISCS
K855206 · Difco Laboratories, Inc. · Jan 1986
CEFACLOR SENSI-DISC
K855135 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1986
GENERAL DIAGNOSTICS CEFTAZIDIME 30 MCG SUSC DISK
K852689 · Warner-Lambert Co. · Aug 1985