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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 / October 2025 / K250085

510(k) cleared

On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System

ACON Laboratories, Inc. · Oct 10, 2025 · K250085

FDA cleared the On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System from ACON Laboratories, Inc. on Oct 10, 2025 under K250085, a traditional 510(k). The device falls under product code NBW, System, Test, Blood Glucose, Over The Counter, regulated at 21 CFR 862.1345 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Jan 13, 2025. The decision came 270 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

ACON Laboratories, Inc. has 3 other decisions in the tracker over the last 12 months: K261212 (Flowflex Plus RSV + Flu A/B + COVID Rapid Test), K251697 (Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip), K251749 (Flowflex Plus RSV + Flu A/B + COVID Home Test).

Questions & Answers

What did FDA clear under K250085?

K250085 is the FDA 510(k) for On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System, submitted by ACON Laboratories, Inc.. FDA's decision date was Oct 10, 2025, under product code NBW (System, Test, Blood Glucose, Over The Counter).

Who makes the On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System?

ACON Laboratories, Inc., based in San Diego, CA, is the applicant of record for K250085.

How long did the K250085 review take?

FDA received the submission on Jan 13, 2025 and issued its decision on Oct 10, 2025, 270 days later.

← All decisions in October 2025

Sources