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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 / K252742

510(k) cleared

Navigated Instruments

Tyber Medical, LLC · Oct 28, 2025 · K252742

FDA cleared the Navigated Instruments from Tyber Medical, LLC on Oct 28, 2025 under K252742, a traditional 510(k). The device falls under product code OLO, Orthopedic Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Aug 28, 2025. The decision came 61 days later, inside the 90 FDA-day goal for a 510(k).

Tyber Medical, LLC has 5 other decisions in the tracker over the last 12 months: K261207 (Exalta Proximal Tibia Plating System), K260810 (Anteralign LS coverplate), K261060 (Navigated LLIF Impactable Tracker), K253042 (Tyber Medical Trauma Screw).

Questions & Answers

What did FDA clear under K252742?

K252742 is the FDA 510(k) for Navigated Instruments, submitted by Tyber Medical, LLC. FDA's decision date was Oct 28, 2025, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the Navigated Instruments?

Tyber Medical, LLC, based in Bethlehem, PA, is the applicant of record for K252742.

How long did the K252742 review take?

FDA received the submission on Aug 28, 2025 and issued its decision on Oct 28, 2025, 61 days later.

← All decisions in October 2025

Sources