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Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours

The Tracker / August 2026 / K254217

510(k) cleared

Aerloom

Evolym, LLC · Aug 31, 2026 · K254217

FDA cleared the Aerloom from Evolym, LLC on Aug 31, 2026 under K254217, a traditional 510(k). The device falls under product code JOW, Sleeve, Limb, Compressible, regulated at 21 CFR 870.5800 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Dec 29, 2025. The decision came 245 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 Evolym, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254217?

K254217 is the FDA 510(k) for Aerloom, submitted by Evolym, LLC. FDA's decision date was Aug 31, 2026, under product code JOW (Sleeve, Limb, Compressible).

Who makes the Aerloom?

Evolym, LLC, based in Wilmington, DE, is the applicant of record for K254217.

How long did the K254217 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Aug 31, 2026, 245 days later.

← All decisions in August 2026