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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / October 2026 / K261612

510(k) cleared

SwiftSight-BodyComposition

Airs Medical, Inc. · Oct 1, 2026 · K261612 · In the directory

FDA cleared the SwiftSight-BodyComposition from Airs Medical, Inc. on Oct 1, 2026 under K261612, a traditional 510(k). The device falls under product code LNH, System, Nuclear Magnetic Resonance Imaging, regulated at 21 CFR 892.1000 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on May 15, 2026. The decision came 139 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Airs Medical, Inc. has 2 other decisions in the tracker over the last 12 months: K261349 (SwiftMR), K253775 (SwiftMR).

Questions & Answers

What did FDA clear under K261612?

K261612 is the FDA 510(k) for SwiftSight-BodyComposition, submitted by Airs Medical, Inc.. FDA's decision date was Oct 1, 2026, under product code LNH (System, Nuclear Magnetic Resonance Imaging).

Who makes the SwiftSight-BodyComposition?

Airs Medical, Inc., based in Seoul, is the applicant of record for K261612. The company is listed in the MedDevice Startups directory.

How long did the K261612 review take?

FDA received the submission on May 15, 2026 and issued its decision on Oct 1, 2026, 139 days later.

← All decisions in October 2026

Sources

In the startup directory

AIRS Medical

Imaging & Radiology · Seoul, South Korea