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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 / K253817

510(k) cleared

IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La

Immunodiagnostics Systems Limited · Aug 21, 2026 · K253817

FDA cleared the IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La from Immunodiagnostics Systems Limited on Aug 21, 2026 under K253817, a traditional 510(k). The device falls under product code LLL, Extractable Antinuclear Antibody, Antigen And Control, regulated at 21 CFR 866.5100 as a Class 2 device. The review panel was Immunology.

FDA logged the submission as received on Nov 28, 2025. The decision came 266 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 Immunodiagnostics Systems Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253817?

K253817 is the FDA 510(k) for IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La, submitted by Immunodiagnostics Systems Limited. FDA's decision date was Aug 21, 2026, under product code LLL (Extractable Antinuclear Antibody, Antigen And Control).

Who makes the IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La?

Immunodiagnostics Systems Limited, based in Boldon, is the applicant of record for K253817.

How long did the K253817 review take?

FDA received the submission on Nov 28, 2025 and issued its decision on Aug 21, 2026, 266 days later.

← All decisions in August 2026