# K260226: ElintMAX Respiratory Monitor (ElintMAX Monitor A1)

- Pathway: 510(k) (Traditional)
- Applicant: Amptron Medical, Inc.
- Decided: Sep 16, 2026 after 233 days
- Product code: BZK (Spirometer, Monitoring (W/Wo Alarm))
- Device class: 2
- Regulation: 21 CFR 868.1850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 26 generations back to K941811 (1994). 152 ancestors in all.
No later device cites it as a predicate yet.
0 of 153 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173181: ExSpiron 1Xi, Respiratory Motion, Inc. (2018) Summary page 5.

## Indications for use
ElintMAX is indicated for use by healthcare professionals in healthcare facilities to monitor breathing in spontaneously breathing adult patients who are hemodynamically stable and are not under active procedural or post-anesthesia sedation. ElintMAX is not indicated for use in intensive care or critical care settings, or during the immediate post-anesthesia recovery period. ElintMAX is a non-invasive monitor that graphically displays changes in lung volume over time and presents estimated values for: • Tidal Volume • Respiratory Rate • Minute Ventilation • Inspiration-to-Expiration Time Ratio (I:E Ratio) • Rapid Shallow Breathing Index (RSBI) ElintMAX is not intended for apnea detection. The device is intended to supplement, not replace, clinical judgment or other diagnostic tools. Its outputs are to be used as supportive inputs in conjunction with other clinical assessments to evaluate respiratory status.

Source page: https://510kreport.com/device/K260226
Methodology: https://510kreport.com/methodology