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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 / K260157

510(k) cleared

LifeLens Physiological Monitor

LifeLens Technologies, Inc. · Jul 9, 2026 · K260157

FDA cleared the LifeLens Physiological Monitor from LifeLens Technologies, Inc. on Jul 9, 2026 under K260157, a traditional 510(k). The device falls under product code DSH, Recorder, Magnetic Tape, Medical, regulated at 21 CFR 870.2800 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 20, 2026. The decision came 170 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 LifeLens Technologies, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260157?

K260157 is the FDA 510(k) for LifeLens Physiological Monitor, submitted by LifeLens Technologies, Inc.. FDA's decision date was Jul 9, 2026, under product code DSH (Recorder, Magnetic Tape, Medical).

Who makes the LifeLens Physiological Monitor?

LifeLens Technologies, Inc., based in Ivyland, PA, is the applicant of record for K260157.

How long did the K260157 review take?

FDA received the submission on Jan 20, 2026 and issued its decision on Jul 9, 2026, 170 days later.

← All decisions in July 2026