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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 / April 2026 / K252207

510(k) cleared

ABL90 FLEX PLUS System, safeCLINITUBES

Radiometer Medicals Aps · Apr 10, 2026 · K252207

FDA cleared the ABL90 FLEX PLUS System, safeCLINITUBES from Radiometer Medicals Aps on Apr 10, 2026 under K252207, a traditional 510(k). The device falls under product code CHL, Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, regulated at 21 CFR 862.1120 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Jul 14, 2025. The decision came 270 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Radiometer Medicals Aps has 2 other decisions in the tracker over the last 12 months: K252475 (ABL90 FLEX PLUS System), K252488 (ABL90 FLEX PLUS System).

Questions & Answers

What did FDA clear under K252207?

K252207 is the FDA 510(k) for ABL90 FLEX PLUS System, safeCLINITUBES, submitted by Radiometer Medicals Aps. FDA's decision date was Apr 10, 2026, under product code CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph).

Who makes the ABL90 FLEX PLUS System, safeCLINITUBES?

Radiometer Medicals Aps, based in Brønshøj, is the applicant of record for K252207.

How long did the K252207 review take?

FDA received the submission on Jul 14, 2025 and issued its decision on Apr 10, 2026, 270 days later.

← All decisions in April 2026

Sources