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 / K262005

510(k) cleared

Affera Integrated Mapping System

Medtronic, Inc. · Aug 21, 2026 · K262005

FDA cleared the Affera Integrated Mapping System from Medtronic, Inc. on Aug 21, 2026 under K262005, a special 510(k). The device falls under product code DQK, Computer, Diagnostic, Programmable, regulated at 21 CFR 870.1425 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 15, 2026. The decision came 67 days later, inside the 90 FDA-day goal for a 510(k).

Medtronic, Inc. has 8 other decisions in the tracker over the last 12 months: K262735 (LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)), K261335 (VitalFlow Set with Balance Biosurface), K261866 (Concerto Versa Detachable Coil), K253530 (Trexon Monofilament Synthetic Absorbable Suture).

Questions & Answers

What did FDA clear under K262005?

K262005 is the FDA 510(k) for Affera Integrated Mapping System, submitted by Medtronic, Inc.. FDA's decision date was Aug 21, 2026, under product code DQK (Computer, Diagnostic, Programmable).

Who makes the Affera Integrated Mapping System?

Medtronic, Inc., based in Mounds View, MN, is the applicant of record for K262005.

How long did the K262005 review take?

FDA received the submission on Jun 15, 2026 and issued its decision on Aug 21, 2026, 67 days later.

← All decisions in August 2026