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 / December 2025 / K253403

510(k) cleared

FemVue® Controlled Saline-Air Device (FSA-300)

Femasys, Inc. · Dec 15, 2025 · K253403

FDA cleared the FemVue® Controlled Saline-Air Device (FSA-300) from Femasys, Inc. on Dec 15, 2025 under K253403, a traditional 510(k). The device falls under product code LKF, Cannula, Manipulator/Injector, Uterine, regulated at 21 CFR 884.4530 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Sep 30, 2025. The decision came 76 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Femasys, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253403?

K253403 is the FDA 510(k) for FemVue® Controlled Saline-Air Device (FSA-300), submitted by Femasys, Inc.. FDA's decision date was Dec 15, 2025, under product code LKF (Cannula, Manipulator/Injector, Uterine).

Who makes the FemVue® Controlled Saline-Air Device (FSA-300)?

Femasys, Inc., based in Cumming, GA, is the applicant of record for K253403.

How long did the K253403 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Dec 15, 2025, 76 days later.

← All decisions in December 2025