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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 / K251790

510(k) cleared

SeptAlign

Spirair, Inc. · Jan 16, 2026 · K251790

FDA cleared the SeptAlign from Spirair, Inc. on Jan 16, 2026 under K251790, a traditional 510(k). The device falls under product code NHB, Polymer, Ear, Nose And Throat, Synthetic, Absorbable, regulated at 21 CFR 874.3620 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Jun 11, 2025. The decision came 219 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Spirair, Inc. has one other decision in the tracker over the last 12 months: K260620 (SeptAlign (SPLN001)).

Questions & Answers

What did FDA clear under K251790?

K251790 is the FDA 510(k) for SeptAlign, submitted by Spirair, Inc.. FDA's decision date was Jan 16, 2026, under product code NHB (Polymer, Ear, Nose And Throat, Synthetic, Absorbable).

Who makes the SeptAlign?

Spirair, Inc., based in South San Francisco, Ca, is the applicant of record for K251790.

How long did the K251790 review take?

FDA received the submission on Jun 11, 2025 and issued its decision on Jan 16, 2026, 219 days later.

← All decisions in January 2026

Sources