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 / K253001

510(k) cleared

KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)

Hunan Ruijiong Biotech Co., Ltd. · Jun 16, 2026 · K253001

FDA cleared the KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) from Hunan Ruijiong Biotech Co., Ltd. on Jun 16, 2026 under K253001, a traditional 510(k). The device falls under product code NHJ, Device, Positive Pressure Breathing, Intermittent, regulated at 21 CFR 868.5905 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Sep 19, 2025. The decision came 270 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 Hunan Ruijiong Biotech Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253001?

K253001 is the FDA 510(k) for KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5), submitted by Hunan Ruijiong Biotech Co., Ltd.. FDA's decision date was Jun 16, 2026, under product code NHJ (Device, Positive Pressure Breathing, Intermittent).

Who makes the KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)?

Hunan Ruijiong Biotech Co., Ltd., based in Xiangtan, is the applicant of record for K253001.

How long did the K253001 review take?

FDA received the submission on Sep 19, 2025 and issued its decision on Jun 16, 2026, 270 days later.

← All decisions in June 2026