Cleared Traditional

K262113 - HardyDisk AST Tebipenem 10µg (TBP10)

K262113 is an FDA 510(k) clearance for HardyDisk AST Tebipenem 10µg (TBP10), 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 58-day FDA review.

K262113 · Hardy Diagnostics · Microbiology device
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Aug 2026
Decision
58d
Days
Class 2
Risk

K262113 is an FDA 510(k) clearance for the HardyDisk AST Tebipenem 10µg (TBP10). 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 August 20, 2026 after a review of 58 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

FDA 510(k) Submission Details - K262113

510(k) Number K262113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2026
Decision Date August 20, 2026
Days to Decision 58 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
44d faster than avg
Panel avg: 102d · This submission: 58d
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 K262113.
Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60
K261781 · Thermo Fisher Scientific (Oxoid Ltd.) · Jul 2026
Gepotidacin GEP 10 µg
K261853 · Liofilchem, Inc. · Jul 2026
HardyDisk AST Gepotidacin 10µg (GEP10)
K260842 · Hardy Diagnostics · May 2026
Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10
K251337 · Thermo Fisher Scientific (Oxoid Ltd.) · Dec 2025
HardyDisk AST Cefiderocol 30µg (FDC30)
K253105 · Hardy Diagnostics · Nov 2025
Sulopenem SPM 2 µg
K251879 · Liofilchem · Aug 2025