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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 / May 2026 / K252643

510(k) cleared

Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled

Teleflex Medical Sdn. Bhd. · May 15, 2026 · K252643

FDA cleared the Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled from Teleflex Medical Sdn. Bhd. on May 15, 2026 under K252643, a traditional 510(k). The device falls under product code CAH, Filter, Bacterial, Breathing-Circuit, regulated at 21 CFR 868.5260 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Aug 21, 2025. The decision came 267 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Teleflex Medical Sdn. Bhd. has 2 other decisions in the tracker over the last 12 months: K262056 (Rusch Latex Gold Foley Catheter), K252537 (Rusch SoftSimplastic Foley Catheters).

Questions & Answers

What did FDA clear under K252643?

K252643 is the FDA 510(k) for Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled, submitted by Teleflex Medical Sdn. Bhd.. FDA's decision date was May 15, 2026, under product code CAH (Filter, Bacterial, Breathing-Circuit).

Who makes the Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled?

Teleflex Medical Sdn. Bhd., based in Kamunting, is the applicant of record for K252643.

How long did the K252643 review take?

FDA received the submission on Aug 21, 2025 and issued its decision on May 15, 2026, 267 days later.

← All decisions in May 2026

Sources