Cleared Traditional

K994091 - HARDYDISK GENTAMICIN

K994091 is the FDA 510(k) clearance for HARDYDISK GENTAMICIN by Hardy Diagnostics. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K994091 · Hardy Diagnostics · Microbiology device
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Feb 2000
Decision
70d
Days
Class 2
Risk

K994091 is an FDA 510(k) clearance for the HARDYDISK GENTAMICIN, 10MCG. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on February 11, 2000 after a review of 70 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 Hardy Diagnostics devices

Submission Details

510(k) Number K994091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1999
Decision Date February 11, 2000
Days to Decision 70 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 102d · This submission: 70d
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 282
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K994091.
HARDYDISK NORFLOXACIN, 10MCG
K994150 · Hardy Diagnostics · Feb 2000
HARDYDISK MEZLOCILLIN 75MCG
K994212 · Hardy Diagnostics · Feb 2000
HARDYDISK CHLORAMPHENICOL, 30MCG
K994089 · Hardy Diagnostics · Feb 2000
HARDYDISK CEFIXIME, 5MCG
K994129 · Hardy Diagnostics · Feb 2000
HARDYDISK CEFACLOR 30MCG
K994046 · Hardy Diagnostics · Feb 2000
HARDYDISK IMIPENEM, 10MCG
K994132 · Hardy Diagnostics · Jan 2000