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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 / January 2026 / K251165

510(k) cleared

Saans (F4-01-00-000-000)

Innaccel Technologies Private Limited · Jan 6, 2026 · K251165

FDA cleared the Saans (F4-01-00-000-000) from Innaccel Technologies Private Limited on Jan 6, 2026 under K251165, a traditional 510(k). The device falls under product code SGR, Noninvasive Positive Airway Pressure System, Facility Use, regulated at 21 CFR 868.5895 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Apr 15, 2025. The decision came 266 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 Innaccel Technologies Private Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251165?

K251165 is the FDA 510(k) for Saans (F4-01-00-000-000), submitted by Innaccel Technologies Private Limited. FDA's decision date was Jan 6, 2026, under product code SGR (Noninvasive Positive Airway Pressure System, Facility Use).

Who makes the Saans (F4-01-00-000-000)?

Innaccel Technologies Private Limited, based in Bengaluru, is the applicant of record for K251165.

How long did the K251165 review take?

FDA received the submission on Apr 15, 2025 and issued its decision on Jan 6, 2026, 266 days later.

← All decisions in January 2026