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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 / February 2026 / K252448

510(k) cleared

AViTA Pulse Oximeter (SP61)

Avita Corporation · Feb 27, 2026 · K252448

FDA cleared the AViTA Pulse Oximeter (SP61) from Avita Corporation on Feb 27, 2026 under K252448, a traditional 510(k). The device falls under product code DQA, Oximeter, regulated at 21 CFR 870.2700 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Aug 4, 2025. The decision came 207 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Avita Corporation has one other decision in the tracker over the last 12 months: K250129 (AViTA Breast Pump).

Questions & Answers

What did FDA clear under K252448?

K252448 is the FDA 510(k) for AViTA Pulse Oximeter (SP61), submitted by Avita Corporation. FDA's decision date was Feb 27, 2026, under product code DQA (Oximeter).

Who makes the AViTA Pulse Oximeter (SP61)?

Avita Corporation, based in New Taipei City, is the applicant of record for K252448.

How long did the K252448 review take?

FDA received the submission on Aug 4, 2025 and issued its decision on Feb 27, 2026, 207 days later.

← All decisions in February 2026