Cleared Traditional

K842252 - CEFONICID 30 MCG SENSI-DISC

K842252 is the FDA 510(k) clearance for CEFONICID 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 43-day FDA review.

K842252 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Jul 1984
Decision
43d
Days
Class 2
Risk

K842252 is an FDA 510(k) clearance for the CEFONICID 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 (Washington, US). The FDA issued a Cleared decision on July 20, 1984 after a review of 43 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 K842252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1984
Decision Date July 20, 1984
Days to Decision 43 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
59d faster than avg
Panel avg: 102d · This submission: 43d
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 K842252.
AUGMENTIN 30 MCG SENSITIVITY DISKS
K843172 · Difco Laboratories, Inc. · Sep 1984
AUGMENTIN 30 MCG SENSI DISC
K842253 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1984
CEFONICID 30 MCG SENSITIVITY DISCS
K842292 · Difco Laboratories, Inc. · Jul 1984
GENERAL DIAG. CEFONICID 30MCG ANTIMIC
K842307 · General Diagnostics · Jul 1984
AZLOCILLIN 75MCG. SENSITIVITY DISCS
K833414 · Difco Laboratories, Inc. · Jan 1984
TICARCILLIN 75MCG. SENSITIVITY DISCS
K833415 · Difco Laboratories, Inc. · Jan 1984