Cleared Traditional

CEFOTAXIME 30MCG ANTIMICROBIAL SUSCEP. (K810427) - FDA 510(k) Clearance

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

K810427 · Pfizer Pharmaceuticals · Microbiology device
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Mar 1981
Decision
41d
Days
Class 2
Risk

K810427 is an FDA 510(k) clearance for the CEFOTAXIME 30MCG ANTIMICROBIAL SUSCEP.. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Pfizer Pharmaceuticals (Mchenry, US). The FDA issued a Cleared decision on March 31, 1981 after a review of 41 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 Pfizer Pharmaceuticals devices

Submission Details

510(k) Number K810427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1981
Decision Date March 31, 1981
Days to Decision 41 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 102d · This submission: 41d
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 79
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K810427.
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
MEZLOCILLIN 75 MCG. SENSI-DISC
K812571 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1981
CEFOTAXIME 30 MCG. SENSI-DISC.
K810564 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1981
MINOCYCLINE 30MCG. SENSI DISC
K802194 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1980
TRIMETHROPRIM 5MCG. SENSI DISC.
K801648 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1980