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 / K262523

510(k) cleared

Amber Arte

Hass Corp. · Oct 16, 2026 · K262523

FDA cleared the Amber Arte from Hass Corp. on Oct 16, 2026 under K262523, a traditional 510(k). The device falls under product code EIH, Powder, Porcelain, regulated at 21 CFR 872.6660 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jul 22, 2026. The decision came 86 days later, inside the 90 FDA-day goal for a 510(k).

Hass Corp. has one other decision in the tracker over the last 12 months: K260859 (Rosetta SM, Rosetta SP).

Questions & Answers

What did FDA clear under K262523?

K262523 is the FDA 510(k) for Amber Arte, submitted by Hass Corp.. FDA's decision date was Oct 16, 2026, under product code EIH (Powder, Porcelain).

Who makes the Amber Arte?

Hass Corp., based in Gangneung, is the applicant of record for K262523.

How long did the K262523 review take?

FDA received the submission on Jul 22, 2026 and issued its decision on Oct 16, 2026, 86 days later.

← All decisions in October 2026