# K223625: CapnoSpot™ Pneumothorax Decompression Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Pneumeric, Inc.
- Decided: Mar 28, 2023 after 113 days
- Product code: GAA (Needle, Aspiration And Injection, Disposable)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K923028 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923028: Turkel Pneumothorax Kit, Symbiosis Corp. (1992) Summary page 5.

## Indications for use
Used for more accurate placement of pneumothorax decompression devices than the current standard of care auditory assessments. The Pneumothorax Decompression Indicator is a colorimetric capnography device indicated to detect the carbon dioxide in the gas passing through the device used to treat pneumothorax with suspected tension physiology.

Source page: https://510kreport.com/device/K223625
Methodology: https://510kreport.com/methodology