ElintMAX Respiratory Monitor (ElintMAX Monitor A1)— 510(k) K260226

Name: FDA 510(k) clearance K260226
Creator: U.S. Food and Drug Administration
Published: 2026-09-16

Substantially Equivalent

Amptron Medical, Inc.

FDA 510(k) clearance K260226 for ElintMAX Respiratory Monitor (ElintMAX Monitor A1), Substantially Equivalent on 2026-09-16. Applicant: Amptron Medical, Inc.. Device class: 2.

Summary

ElintMAX Respiratory Monitor (ElintMAX Monitor A1) is from Amptron Medical, Inc., filed under product code BZK (Spirometer, Monitoring (W/Wo Alarm)). The record doesn't describe the monitor beyond its name and code.

Class II, 21 CFR 868.1850. Anesthesiology is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.

Amptron filed from Carlsbad, California. The decision came 233 calendar days after FDA received it (January 26 to September 16, 2026).

Clearance details

Applicant: Amptron Medical, Inc.
Product code: Product code BZK
Device class: Class 2
Regulation: 21 CFR 868.1850
Advisory panel: Anesthesiology
Date received: 2026-01-26
Decision date: 2026-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BZK

product code BZK

Death: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.