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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 / K253694

510(k) cleared

Natural Cycles

Natural Cycles Nordic AB · Jul 17, 2026 · K253694

FDA cleared the Natural Cycles from Natural Cycles Nordic AB on Jul 17, 2026 under K253694, a traditional 510(k). The device falls under product code PYT, Device, Fertility Diagnostic, Contraceptive, Software Application, regulated at 21 CFR 884.5370 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Nov 21, 2025. The decision came 238 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 Natural Cycles Nordic AB in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253694?

K253694 is the FDA 510(k) for Natural Cycles, submitted by Natural Cycles Nordic AB. FDA's decision date was Jul 17, 2026, under product code PYT (Device, Fertility Diagnostic, Contraceptive, Software Application).

Who makes the Natural Cycles?

Natural Cycles Nordic AB, based in Stockholm, is the applicant of record for K253694.

How long did the K253694 review take?

FDA received the submission on Nov 21, 2025 and issued its decision on Jul 17, 2026, 238 days later.

← All decisions in July 2026