# K182362: MaxCap Ped and MaxCap Neo

- Pathway: 510(k) (Traditional)
- Applicant: Maxtec, LLC
- Decided: May 23, 2019 after 266 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: 4 generations back to K950387 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
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 4.
- K083056: Neo-Stat CO2 <KG, Mercury Medical (2009) Summary page 4.

## Indications for use
The Maxtec MaxCap Neo and MaxCap Ped are 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. Patient Population: MaxCap Neo is intended for use with neonates and infants 250g to 6kg. MaxCap Ped is intended for use with pediatric patients 1kg to 15kg Environment of Use: Hospital, sub-acute, pre-hospital, transport.

Source page: https://510kreport.com/device/K182362
Methodology: https://510kreport.com/methodology