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 / K254094

510(k) cleared

Endox High Level Disinfectant

Whiteley USA, Inc. · Oct 16, 2026 · K254094

FDA cleared the Endox High Level Disinfectant from Whiteley USA, Inc. on Oct 16, 2026 under K254094, a traditional 510(k). The device falls under product code MED, Sterilant, Medical Devices, regulated at 21 CFR 880.6885 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Dec 19, 2025. The decision came 301 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 Whiteley USA, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254094?

K254094 is the FDA 510(k) for Endox High Level Disinfectant, submitted by Whiteley USA, Inc.. FDA's decision date was Oct 16, 2026, under product code MED (Sterilant, Medical Devices).

Who makes the Endox High Level Disinfectant?

Whiteley USA, Inc., based in Wilmington, DE, is the applicant of record for K254094.

How long did the K254094 review take?

FDA received the submission on Dec 19, 2025 and issued its decision on Oct 16, 2026, 301 days later.

← All decisions in October 2026