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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 / September 2026 / K260035

510(k) cleared

Digital Indeflator INFLANTE

UAB Telemedicina · Sep 4, 2026 · K260035

FDA cleared the Digital Indeflator INFLANTE from UAB Telemedicina on Sep 4, 2026 under K260035, a traditional 510(k). The device falls under product code MAV, Syringe, Balloon Inflation, regulated at 21 CFR 870.1650 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 6, 2026. The decision came 241 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 UAB Telemedicina in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260035?

K260035 is the FDA 510(k) for Digital Indeflator INFLANTE, submitted by UAB Telemedicina. FDA's decision date was Sep 4, 2026, under product code MAV (Syringe, Balloon Inflation).

Who makes the Digital Indeflator INFLANTE?

UAB Telemedicina, based in Kaunas, is the applicant of record for K260035.

How long did the K260035 review take?

FDA received the submission on Jan 6, 2026 and issued its decision on Sep 4, 2026, 241 days later.

← All decisions in September 2026