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 / July 2026 / K252243

510(k) cleared

Fastplex BCR-ABL (p210) %IS digital PCR Kit

Suzhou Precigenome, Ltd. Co; · Jul 2, 2026 · K252243

FDA cleared the Fastplex BCR-ABL (p210) %IS digital PCR Kit from Suzhou Precigenome, Ltd. Co; on Jul 2, 2026 under K252243, a traditional 510(k). The device falls under product code OYX, Bcr/Abl1 Monitoring Test, regulated at 21 CFR 866.6060 as a Class 2 device. The review panel was Medical Genetics.

FDA logged the submission as received on Jul 18, 2025. The decision came 349 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Suzhou Precigenome, Ltd. Co; in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252243?

K252243 is the FDA 510(k) for Fastplex BCR-ABL (p210) %IS digital PCR Kit, submitted by Suzhou Precigenome, Ltd. Co;. FDA's decision date was Jul 2, 2026, under product code OYX (Bcr/Abl1 Monitoring Test).

Who makes the Fastplex BCR-ABL (p210) %IS digital PCR Kit?

Suzhou Precigenome, Ltd. Co;, based in Suzhou, is the applicant of record for K252243.

How long did the K252243 review take?

FDA received the submission on Jul 18, 2025 and issued its decision on Jul 2, 2026, 349 days later.

← All decisions in July 2026