Cleared Traditional

K855135 - CEFACLOR SENSI-DISC

K855135 is an FDA 510(k) clearance for CEFACLOR SENSI-DISC, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Microbiology device with product code JTN cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K855135 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Jan 1986
Decision
21d
Days
Class 2
Risk

K855135 is an FDA 510(k) clearance for the CEFACLOR 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 January 13, 1986 after a review of 21 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

FDA 510(k) Submission Details - K855135

510(k) Number K855135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1985
Decision Date January 13, 1986
Days to Decision 21 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
81d faster than avg
Panel avg: 102d · This submission: 21d
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 313
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K855135.
CEFOTETAN 30 MCG SENSITIVITY DISCS
K860527 · Difco Laboratories, Inc. · Mar 1986
CEFOTETAN 30 MCG SENSI DISC
K860536 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1986
CEFACLOR 30 MCG SENSITIVITY DISCS
K855206 · Difco Laboratories, Inc. · Jan 1986
GENERAL DIAGNOSTICS CEFTAZIDIME 30 MCG SUSC DISK
K852689 · Warner-Lambert Co. · Aug 1985
CEFTAZIDIME 30MCG. SENI-DISC
K852873 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1985
GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK
K852967 · Warner-Lambert Co. · Aug 1985