# K121017: Capnography Pad (92516)

- Pathway: 510(k) (Special)
- Applicant: Spacelabs Healthcare
- Decided: Jul 13, 2012 after 100 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 K001814 (2000). 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)
- K112173: Speacelabs Multigas Module, Spacelabs Healthcare (2011) Summary page 1.

## Most influential descendants
- K130112: Capno Module, 92517 (2013), 0 descendants of its own

## Indications for use
The Spacelabs Healthcare Capnography Pod, Model 92516 (CapnoPod) is intended to provide a means of monitoring carbon dioxide and respiration rate and alert clinical personnel when the concentration moves outside of user-defined limits. The CapnoPod is intended to be used with and controlled by a Spacelabs Healthcare monitors. The CapnoPod is intended to be used for monitoring adult, pediatric and neonate patients, under the direction of qualified medical personnel.

Source page: https://510kreport.com/device/K121017
Methodology: https://510kreport.com/methodology