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Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries

The Tracker / August 2026 / K262113

510(k) cleared

HardyDisk AST Tebipenem 10µg (TBP10)

Hardy Diagnostics · Aug 20, 2026 · K262113

FDA cleared the HardyDisk AST Tebipenem 10µg (TBP10) from Hardy Diagnostics on Aug 20, 2026 under K262113, a traditional 510(k). The device falls under product code JTN, Susceptibility Test Discs, Antimicrobial, regulated at 21 CFR 866.1620 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Jun 23, 2026. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

Hardy Diagnostics has 2 other decisions in the tracker over the last 12 months: K260842 (HardyDisk AST Gepotidacin 10µg (GEP10)), K253105 (HardyDisk AST Cefiderocol 30µg (FDC30)).

Questions & Answers

What did FDA clear under K262113?

K262113 is the FDA 510(k) for HardyDisk AST Tebipenem 10µg (TBP10), submitted by Hardy Diagnostics. FDA's decision date was Aug 20, 2026, under product code JTN (Susceptibility Test Discs, Antimicrobial).

Who makes the HardyDisk AST Tebipenem 10µg (TBP10)?

Hardy Diagnostics, based in Santa Maria, CA, is the applicant of record for K262113.

How long did the K262113 review take?

FDA received the submission on Jun 23, 2026 and issued its decision on Aug 20, 2026, 58 days later.

← All decisions in August 2026

Sources