# K083056: Neo-Stat CO2 <KG

- Pathway: 510(k) (Traditional)
- Applicant: Mercury Medical
- Decided: Feb 23, 2009 after 132 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: 3 generations back to K950387 (1995). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031411: Mini STATCO2 CO2 Detector, Model 10-55371, Mercury Medical (2003) Summary page 1.
- K944400: Pedi-Cap, Nellcor, Inc. (1994) Summary page 1.
- K024300: Microcap Plus/NPB-75, Oridion Medical 1987, Ltd. (2003) Summary page 1.

## Most influential descendants
- K182362: MaxCap Ped and MaxCap Neo (2019), 0 descendants of its own

## Indications for use
The Neo-StatCO₂ <Kg is indicated to provide a semi-quantitative visualization of the CO₂ in the patient airway. It is an adjunct in patient assessment to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician. Intended for use with neonate and infant patients from 250g to 6 kg.

Source page: https://510kreport.com/device/K083056
Methodology: https://510kreport.com/methodology