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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 / July 2026 / K252042

510(k) cleared

Sync AV II Temporary Pacing Catheter

Swift Sync, Inc. · Jul 30, 2026 · K252042

FDA cleared the Sync AV II Temporary Pacing Catheter from Swift Sync, Inc. on Jul 30, 2026 under K252042, a traditional 510(k). The device falls under product code LDF, Electrode, Pacemaker, Temporary, regulated at 21 CFR 870.3680 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 30, 2025. The decision came 395 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 Swift Sync, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252042?

K252042 is the FDA 510(k) for Sync AV II Temporary Pacing Catheter, submitted by Swift Sync, Inc.. FDA's decision date was Jul 30, 2026, under product code LDF (Electrode, Pacemaker, Temporary).

Who makes the Sync AV II Temporary Pacing Catheter?

Swift Sync, Inc., based in Miami Shores, FL, is the applicant of record for K252042.

How long did the K252042 review take?

FDA received the submission on Jun 30, 2025 and issued its decision on Jul 30, 2026, 395 days later.

← All decisions in July 2026