WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K253542

510(k) cleared

Apollo Quattro (APQ-10M)

Weero Co., Ltd. · Jun 8, 2026 · K253542

FDA cleared the Apollo Quattro (APQ-10M) from Weero Co., Ltd. on Jun 8, 2026 under K253542, a traditional 510(k). The device falls under product code IPF, Stimulator, Muscle, Powered, regulated at 21 CFR 890.5850 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Nov 14, 2025. The decision came 206 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Weero Co., Ltd. has one other decision in the tracker over the last 12 months: K253261 (Apollo Quattro (APQ-10M)).

Questions & Answers

What did FDA clear under K253542?

K253542 is the FDA 510(k) for Apollo Quattro (APQ-10M), submitted by Weero Co., Ltd.. FDA's decision date was Jun 8, 2026, under product code IPF (Stimulator, Muscle, Powered).

Who makes the Apollo Quattro (APQ-10M)?

Weero Co., Ltd., based in Suwon, is the applicant of record for K253542.

How long did the K253542 review take?

FDA received the submission on Nov 14, 2025 and issued its decision on Jun 8, 2026, 206 days later.

← All decisions in June 2026

Sources