WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home

The Tracker / September 2026 / K260226

510(k) cleared

ElintMAX Respiratory Monitor (ElintMAX Monitor A1)

Amptron Medical, Inc. · Sep 16, 2026 · K260226

FDA cleared the ElintMAX Respiratory Monitor (ElintMAX Monitor A1) from Amptron Medical, Inc. on Sep 16, 2026 under K260226, a traditional 510(k). The device falls under product code BZK, Spirometer, Monitoring (W/Wo Alarm), regulated at 21 CFR 868.1850 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Jan 26, 2026. The decision came 233 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 Amptron Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260226?

K260226 is the FDA 510(k) for ElintMAX Respiratory Monitor (ElintMAX Monitor A1), submitted by Amptron Medical, Inc.. FDA's decision date was Sep 16, 2026, under product code BZK (Spirometer, Monitoring (W/Wo Alarm)).

Who makes the ElintMAX Respiratory Monitor (ElintMAX Monitor A1)?

Amptron Medical, Inc., based in Carlsbad, CA, is the applicant of record for K260226.

How long did the K260226 review take?

FDA received the submission on Jan 26, 2026 and issued its decision on Sep 16, 2026, 233 days later.

← All decisions in September 2026