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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 / June 2026 / K253196

510(k) cleared

Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)

Midmark Corporation · Jun 12, 2026 · K253196

FDA cleared the Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) from Midmark Corporation on Jun 12, 2026 under K253196, a traditional 510(k). The device falls under product code MWI, Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), regulated at 21 CFR 870.2300 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 26, 2025. The decision came 259 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Midmark Corporation has one other decision in the tracker over the last 12 months: K251626 (Midmark Dental Delivery System).

Questions & Answers

What did FDA clear under K253196?

K253196 is the FDA 510(k) for Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400), submitted by Midmark Corporation. FDA's decision date was Jun 12, 2026, under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)).

Who makes the Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)?

Midmark Corporation, based in Versailles, OH, is the applicant of record for K253196.

How long did the K253196 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Jun 12, 2026, 259 days later.

← All decisions in June 2026

Sources