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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 / September 2025 / K251597

510(k) cleared

InnerView System

Perimetrics, Inc. · Sep 18, 2025 · K251597

FDA cleared the InnerView System from Perimetrics, Inc. on Sep 18, 2025 under K251597, a traditional 510(k). The device falls under product code EKX, Handpiece, Direct Drive, Ac-Powered, regulated at 21 CFR 872.4200 as a Class 1 device. The review panel was Dental.

FDA logged the submission as received on May 27, 2025. The decision came 114 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 Perimetrics, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251597?

K251597 is the FDA 510(k) for InnerView System, submitted by Perimetrics, Inc.. FDA's decision date was Sep 18, 2025, under product code EKX (Handpiece, Direct Drive, Ac-Powered).

Who makes the InnerView System?

Perimetrics, Inc., based in Redmond, WA, is the applicant of record for K251597.

How long did the K251597 review take?

FDA received the submission on May 27, 2025 and issued its decision on Sep 18, 2025, 114 days later.

← All decisions in September 2025