# K920338: Companion Retrofit Oxygen Concentration Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Puritan Bennett Corp.
- Decided: Aug 27, 1992 after 216 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 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
- K984295: Invacare Check O2 Plus Concentrator Analyzer (Check O2 Plus) (1999), 4 descendants of its own
- K072469: Digiflo Concentrator Analyzer (2008), 3 descendants of its own
- K112402: ULTRAMAXO2 Oxygen Analyer (2011), 2 descendants of its own
- K261389: PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) (2026), 0 descendants of its own
- K250002: Smart Check O2 (MA0236) (2025), 0 descendants of its own

Source page: https://510kreport.com/device/K920338
Methodology: https://510kreport.com/methodology