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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 / K261389

510(k) cleared

PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)

Salter Labs · Jul 30, 2026 · K261389

FDA cleared the PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) from Salter Labs on Jul 30, 2026 under K261389, a traditional 510(k). The device falls under product code CCL, Analyzer, Gas, Oxygen, Gaseous-Phase, regulated at 21 CFR 868.1720 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Apr 28, 2026. The decision came 93 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 Salter Labs in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261389?

K261389 is the FDA 510(k) for PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1), submitted by Salter Labs. FDA's decision date was Jul 30, 2026, under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase).

Who makes the PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)?

Salter Labs, based in El Paso, TX, is the applicant of record for K261389.

How long did the K261389 review take?

FDA received the submission on Apr 28, 2026 and issued its decision on Jul 30, 2026, 93 days later.

← All decisions in July 2026