# K201590: EMMA Capnograph

- Pathway: 510(k) (Special)
- Applicant: Masimo Corporation
- Decided: Mar 29, 2021 after 290 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K935370 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072813: Emma Analyzer (Kpa & MMHG); Emma Monitor (Kpa & MMHG), Phasein AB (2007) Summary page 4.

## Indications for use
EMMA® Capnograph measures, displays and monitors carbon dioxide partial pressure and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients.

Source page: https://510kreport.com/device/K201590
Methodology: https://510kreport.com/methodology