# K944400: Pedi-Cap

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor, Inc.
- Decided: Sep 27, 1994 after 19 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 7 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K960468: DMR/CO2 Combo Kti (1996), 6 descendants of its own
- K973419: DMR Plus Disposable Manual Resuscitator (1998), 5 descendants of its own
- K031411: Mini STATCO2 CO2 Detector, Model 10-55371 (2003), 3 descendants of its own
- K083056: Neo-Stat CO2 <KG (2009), 1 descendant of its own
- K042572: Kendall CO2NFIRM Now CO2 Detector (2004), 1 descendant of its own

## Recalls of this device
- Aug 14, 2009 · Not classified · Z-2047-2009: CO2 detector may increase resistance to air flow in an intubated patient.

Source page: https://510kreport.com/device/K944400
Methodology: https://510kreport.com/methodology