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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 / May 2026 / K252488

510(k) cleared

ABL90 FLEX PLUS System

Radiometer Medicals Aps · May 1, 2026 · K252488

FDA cleared the ABL90 FLEX PLUS System from Radiometer Medicals Aps on May 1, 2026 under K252488, a traditional 510(k). The device falls under product code CGA, Glucose Oxidase, Glucose, regulated at 21 CFR 862.1345 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Aug 8, 2025. The decision came 266 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), K252207 (ABL90 FLEX PLUS System, safeCLINITUBES).

Questions & Answers

What did FDA clear under K252488?

K252488 is the FDA 510(k) for ABL90 FLEX PLUS System, submitted by Radiometer Medicals Aps. FDA's decision date was May 1, 2026, under product code CGA (Glucose Oxidase, Glucose).

Who makes the ABL90 FLEX PLUS System?

Radiometer Medicals Aps, based in Brønshøj, is the applicant of record for K252488.

How long did the K252488 review take?

FDA received the submission on Aug 8, 2025 and issued its decision on May 1, 2026, 266 days later.

← All decisions in May 2026

Sources