Cleared Traditional

K241060 - HardyDisk AST Cefiderocol 30µg (FDC30)

K241060 is an FDA 510(k) clearance for HardyDisk AST Cefiderocol 30µg (FDC30), manufactured by Hardy Diagnostics. The device is a Class 2 Microbiology device with product code JTN cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K241060 · Hardy Diagnostics · Microbiology device
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Jul 2024
Decision
91d
Days
Class 2
Risk

K241060 is an FDA 510(k) clearance for the HardyDisk AST Cefiderocol 30µg (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 July 18, 2024 after a review of 91 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hardy Diagnostics devices

FDA 510(k) Submission Details - K241060

510(k) Number K241060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2024
Decision Date July 18, 2024
Days to Decision 91 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 102d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

JTN Device Classification - Class 2, Special Controls

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 323
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K241060.
Ceftobiprole BPR 5 µg Disc
K250885 · Liofilchem, Inc. · Jun 2025
Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50
K250789 · Thermo Fisher Scientific (Oxoid Ltd.) · Jun 2025
HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)
K250454 · Hardy Diagnostics · May 2025
Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5
K231806 · Oxoid Limited (Part of Thermo Fisher Scientific) · Mar 2024
Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20
K232276 · Oxoid Limited (Part of Thermo Fisher Scientific) · Oct 2023
HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)
K231568 · Hardy Diagnostics · Jul 2023