WHERE ARE YOU?

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

THE TAPE

FDA posts two worked PCCP examples for machine learning devices Haemonetics wins FDA approval for a patch that seals 26F arteriotomies FDA adds Olympus enteroscopes and capsule systems to Import Alert 89-04 Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans AdvaMed plans industry cybersecurity standards written like a code of ethics Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Paradromics hands Siemens Healthineers the imaging workup for its brain implant FDA posts two worked PCCP examples for machine learning devices Haemonetics wins FDA approval for a patch that seals 26F arteriotomies FDA adds Olympus enteroscopes and capsule systems to Import Alert 89-04 Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans AdvaMed plans industry cybersecurity standards written like a code of ethics Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Paradromics hands Siemens Healthineers the imaging workup for its brain implant

The Tracker / October 2026 / K262042

510(k) cleared

Sterilization Cassette (CASS-1)

Alliedstar Medical Equipment Co., Ltd. · Oct 14, 2026 · K262042

FDA cleared the Sterilization Cassette (CASS-1) from Alliedstar Medical Equipment Co., Ltd. on Oct 14, 2026 under K262042, a traditional 510(k). The device falls under product code KCT, Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, regulated at 21 CFR 880.6850 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jun 17, 2026. The decision came 119 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 Alliedstar Medical Equipment Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262042?

K262042 is the FDA 510(k) for Sterilization Cassette (CASS-1), submitted by Alliedstar Medical Equipment Co., Ltd.. FDA's decision date was Oct 14, 2026, under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories).

Who makes the Sterilization Cassette (CASS-1)?

Alliedstar Medical Equipment Co., Ltd., based in Ziyang, is the applicant of record for K262042.

How long did the K262042 review take?

FDA received the submission on Jun 17, 2026 and issued its decision on Oct 14, 2026, 119 days later.

← All decisions in October 2026