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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 / K260613

510(k) cleared

AMI Plasma Cartridge, AMI

Sequitur Health Corp. · Sep 1, 2026 · K260613

FDA cleared the AMI Plasma Cartridge, AMI from Sequitur Health Corp. on Sep 1, 2026 under K260613, a traditional 510(k). The device falls under product code JID, Photometric Method, Ammonia, regulated at 21 CFR 862.1065 as a Class 1 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Feb 25, 2026. The decision came 188 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 Sequitur Health Corp. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260613?

K260613 is the FDA 510(k) for AMI Plasma Cartridge, AMI, submitted by Sequitur Health Corp.. FDA's decision date was Sep 1, 2026, under product code JID (Photometric Method, Ammonia).

Who makes the AMI Plasma Cartridge, AMI?

Sequitur Health Corp., based in Phoenix, AZ, is the applicant of record for K260613.

How long did the K260613 review take?

FDA received the submission on Feb 25, 2026 and issued its decision on Sep 1, 2026, 188 days later.

← All decisions in September 2026