WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

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 / K261142

510(k) cleared

Ponto 5 Mini; Ponto 5 Superpower

Oticon Medical AB · Aug 26, 2026 · K261142

FDA cleared the Ponto 5 Mini; Ponto 5 Superpower from Oticon Medical AB on Aug 26, 2026 under K261142, a special 510(k). The device falls under product code MAH, Hearing Aid, Bone Conduction, Implanted, regulated at 21 CFR 874.3302 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Apr 7, 2026. The decision came 141 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Oticon Medical AB in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261142?

K261142 is the FDA 510(k) for Ponto 5 Mini; Ponto 5 Superpower, submitted by Oticon Medical AB. FDA's decision date was Aug 26, 2026, under product code MAH (Hearing Aid, Bone Conduction, Implanted).

Who makes the Ponto 5 Mini; Ponto 5 Superpower?

Oticon Medical AB, based in Askim, is the applicant of record for K261142.

How long did the K261142 review take?

FDA received the submission on Apr 7, 2026 and issued its decision on Aug 26, 2026, 141 days later.

← All decisions in August 2026