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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / September 2025 / K250093

510(k) cleared

Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)

Linshom Medical, Inc. · Sep 26, 2025 · K250093

FDA cleared the Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) from Linshom Medical, Inc. on Sep 26, 2025 under K250093, a traditional 510(k). The device falls under product code BZQ, Monitor, Breathing Frequency, regulated at 21 CFR 868.2375 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Jan 14, 2025. The decision came 255 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 Linshom Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250093?

K250093 is the FDA 510(k) for Linshom Continuous Predictive Respiratory Monitoring System (CPRMS), submitted by Linshom Medical, Inc.. FDA's decision date was Sep 26, 2025, under product code BZQ (Monitor, Breathing Frequency).

Who makes the Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)?

Linshom Medical, Inc., based in Ellicott City, MD, is the applicant of record for K250093.

How long did the K250093 review take?

FDA received the submission on Jan 14, 2025 and issued its decision on Sep 26, 2025, 255 days later.

← All decisions in September 2025