WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

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 / May 2026 / K253237

510(k) cleared

Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)

Elde Medikal Sanayi ve Ticaret Anonim Sirketi · May 8, 2026 · K253237

FDA cleared the Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) from Elde Medikal Sanayi ve Ticaret Anonim Sirketi on May 8, 2026 under K253237, a traditional 510(k). The device falls under product code GXY, Electrode, Cutaneous, regulated at 21 CFR 882.1320 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Sep 29, 2025. The decision came 221 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 Elde Medikal Sanayi ve Ticaret Anonim Sirketi in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253237?

K253237 is the FDA 510(k) for Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode), submitted by Elde Medikal Sanayi ve Ticaret Anonim Sirketi. FDA's decision date was May 8, 2026, under product code GXY (Electrode, Cutaneous).

Who makes the Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)?

Elde Medikal Sanayi ve Ticaret Anonim Sirketi, based in Umraniye/Istanbul, is the applicant of record for K253237.

How long did the K253237 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on May 8, 2026, 221 days later.

← All decisions in May 2026