Cleared Traditional

OFLOXACIN, 5 MCG SENSI-DISC (K910506) - FDA 510(k) Clearance

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

K910506 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Mar 1991
Decision
27d
Days
Class 2
Risk

K910506 is an FDA 510(k) clearance for the OFLOXACIN, 5 MCG SENSI-DISC. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on March 4, 1991 after a review of 27 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 K910506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1991
Decision Date March 04, 1991
Days to Decision 27 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
75d faster than avg
Panel avg: 102d · This submission: 27d
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 K910506.
TEMAFLOXCIN, 5MCG, SENSI DISC
K920787 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
CEFPROZIL 30MCG, SENSI DISC
K920473 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1992
CLARITHROMYCIN 15MCG SENSI DISC
K920131 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992
CEFMATZOLE 30 MCG SENSI DISC
K895679 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1990
SPECTINOMYCIN 100 MCG SENSI-DISC
K891772 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1989
CEFIXIME, 5 MCG SENSI-DISC ANTIMIC SUSCEP TEST DIS
K893754 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1989