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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 / October 2025 / K252931

510(k) cleared

Invisalign® Palatal Expander System

Align Technology, Inc. · Oct 23, 2025 · K252931

FDA cleared the Invisalign® Palatal Expander System from Align Technology, Inc. on Oct 23, 2025 under K252931, a special 510(k). The device falls under product code NXC, Aligner, Sequential, regulated at 21 CFR 872.5470 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Sep 15, 2025. The decision came 38 days later, inside the 90 FDA-day goal for a 510(k).

Align Technology, Inc. has 2 other decisions in the tracker over the last 12 months: K261847 (iTero Lumina Pro), K252870 (Invisalign Specifix Attachment System).

Questions & Answers

What did FDA clear under K252931?

K252931 is the FDA 510(k) for Invisalign® Palatal Expander System, submitted by Align Technology, Inc.. FDA's decision date was Oct 23, 2025, under product code NXC (Aligner, Sequential).

Who makes the Invisalign® Palatal Expander System?

Align Technology, Inc., based in San Jose, CA, is the applicant of record for K252931.

How long did the K252931 review take?

FDA received the submission on Sep 15, 2025 and issued its decision on Oct 23, 2025, 38 days later.

← All decisions in October 2025

Sources