# K261389: PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)

- Pathway: 510(k) (Traditional)
- Applicant: Salter Labs
- Decided: Jul 30, 2026 after 93 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 6.

## Indications for use
The PRO2 Elite Plus Oxygen Analyzer is intended as a tool to be used by qualified personnel to spot-check oxygen concentration, flow, and pressure of a delivered air/oxygen mixture of an oxygen concentrator. The Oxygen Analyzer 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. The Oxygen Analyzer is not intended for use in continuous monitoring of oxygen delivery to patients.

Source page: https://510kreport.com/device/K261389
Methodology: https://510kreport.com/methodology