Cleared Traditional

CEFOPERAZONE 75MCG SENSI-DISC (K821264) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K821264 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Jun 1982
Decision
50d
Days
Class 2
Risk

K821264 is an FDA 510(k) clearance for the CEFOPERAZONE 75MCG 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 June 22, 1982 after a review of 50 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 K821264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1982
Decision Date June 22, 1982
Days to Decision 50 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
52d faster than avg
Panel avg: 102d · This submission: 50d
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 78
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K821264.
NETILMICIN 30 MCG SENSI DISC
K830732 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1983
AZLOCILLIN 75MCG SENSI-DISC
K823800 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1983
TICARCILLIN 75MCG. SENSI-DISC
K822832 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1982
PIPERACILLIN 100 MCG. SENSI DISC
K813441 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1981
METRONIDAZOLE 80MCG. SENSI-DISC
K813387 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1981
MOXALACTAM 30MCG. SENSI-DISC
K812844 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1981