# K984295: Invacare Check O2 Plus Concentrator Analyzer (Check O2 Plus)

- Pathway: 510(k) (Traditional)
- Applicant: Invacare Corp.
- Decided: Jul 9, 1999 after 220 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: 1 generation back to K920338 (1992). 1 ancestor in all.
4 later devices descend from it; 2 cite 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)
- K920338: Companion Retrofit Oxygen Concentration Indicator, Puritan Bennett Corp. (1992) Summary page 1.

## Most influential descendants
- 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

## Indications for use
The Invacare Check O2 Concentrator Analyzer device is a tool for use by service personnel to evaluate the output of an oxygen concentrator. Its intended use is to provide information to the service technician regarding oxygen content, flow rate, and pressure, of oxygen produced by an oxygen concentrator. It is not intended to be used by patients who are prescribed oxygen, nor is it intended to continuously monitor or confirm oxygen delivery to patient. The Check O2 has measurement capability in the following ranges: 73% - 95.6% Oxygen Concentration 0 - 6 LPM Flow 0 - 10 PSI Pressure Accuracy of the Device is: + 2% Oxygen Concentration £.3 L/M Flow (5% of full scale) + 1 digit + 2 PSI Full Scale Pressure 0 to 68.95 kPa, + 2% Full Scale Intended Environment: The Check O2 is intended to be used in an environment where Oxygen Concentrators are 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/K984295
Methodology: https://510kreport.com/methodology