Cleared Traditional

K193504 - HardyDisk AST Cefiderocol 30ug (FDC30)

K193504 is the FDA 510(k) clearance for HardyDisk AST Cefiderocol 30ug (FDC30) by Hardy Diagnostics. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K193504 · Hardy Diagnostics · Microbiology device
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Jan 2020
Decision
36d
Days
Class 2
Risk

K193504 is an FDA 510(k) clearance for the HardyDisk AST Cefiderocol 30ug (FDC30). 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 January 23, 2020 after a review of 36 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 K193504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2019
Decision Date January 23, 2020
Days to Decision 36 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
66d faster than avg
Panel avg: 102d · This submission: 36d
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 K193504.
Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20
K210873 · Oxoid Limited (Part of Thermo Fisher Scientific) · Oct 2021
Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30
K203700 · Oxoid Limited (Part of Thermo Fisher Scientific) · Jul 2021
Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20
K193508 · Oxoid Limited (Part of Thermo Fisher Scientific) · Dec 2020
HardyDisk AST Lefamulin 20µg (LMU20)
K192326 · Hardy Diagnostics · Sep 2019
HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)
K191931 · Hardy Diagnostics · Jul 2019
HardyDisk AST Omadacycline 30µg (OMC30)
K183298 · Hardy Diagnostics · Jan 2019