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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 / November 2025 / K252677

510(k) cleared

Polyshield Safety IV Catheters

Poly Medicure Limited · Nov 5, 2025 · K252677

FDA cleared the Polyshield Safety IV Catheters from Poly Medicure Limited on Nov 5, 2025 under K252677, a special 510(k). The device falls under product code FOZ, Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, regulated at 21 CFR 880.5200 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Aug 25, 2025. The decision came 72 days later, inside the 90 FDA-day goal for a 510(k).

Poly Medicure Limited has one other decision in the tracker over the last 12 months: K252513 (Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)).

Questions & Answers

What did FDA clear under K252677?

K252677 is the FDA 510(k) for Polyshield Safety IV Catheters, submitted by Poly Medicure Limited. FDA's decision date was Nov 5, 2025, under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days).

Who makes the Polyshield Safety IV Catheters?

Poly Medicure Limited, based in Faridabad, is the applicant of record for K252677.

How long did the K252677 review take?

FDA received the submission on Aug 25, 2025 and issued its decision on Nov 5, 2025, 72 days later.

← All decisions in November 2025

Sources