# K250002: Smart Check O2 (MA0236)

- Pathway: 510(k) (Traditional)
- Applicant: Life Spark Medical, LLC
- Decided: Apr 24, 2025 after 112 days
- Product code: CCL (Analyzer, Gas, Oxygen, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1720
- 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 K920338 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112402: ULTRAMAXO2 Oxygen Analyer, Maxtec, LLC (2011) Summary page 5.

## Indications for use
The Smart Check O2 is a tool used to measure oxygen purity, flow and pressure at the outlet of an oxygen concentrator. The Smart Check is intended to be used in an environment where oxygen concentrators are being serviced or repaired. This includes hospitals, nursing homes, extended care facilities, patient homes, and respiratory device service and repair centers.

Source page: https://510kreport.com/device/K250002
Methodology: https://510kreport.com/methodology