WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

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 / K253673

510(k) cleared

Mcare System (MW-20)

Marani Health, Inc. · Sep 3, 2026 · K253673

FDA cleared the Mcare System (MW-20) from Marani Health, Inc. on Sep 3, 2026 under K253673, a traditional 510(k). The device falls under product code LQK, Home Uterine Activity Monitor, regulated at 21 CFR 884.2730 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Nov 21, 2025. The decision came 286 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 Marani Health, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253673?

K253673 is the FDA 510(k) for Mcare System (MW-20), submitted by Marani Health, Inc.. FDA's decision date was Sep 3, 2026, under product code LQK (Home Uterine Activity Monitor).

Who makes the Mcare System (MW-20)?

Marani Health, Inc., based in Oakdale, MN, is the applicant of record for K253673.

How long did the K253673 review take?

FDA received the submission on Nov 21, 2025 and issued its decision on Sep 3, 2026, 286 days later.

← All decisions in September 2026