# K112402: ULTRAMAXO2 Oxygen Analyer

- Pathway: 510(k) (Abbreviated)
- Applicant: Maxtec, LLC
- Decided: Dec 14, 2011 after 114 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: 3 generations back to K920338 (1992). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072469: Digiflo Concentrator Analyzer, Digiflo, Inc. (2008) Summary page 1.
- K984295: Invacare Check O2 Plus Concentrator Analyzer (Check O2 Plus), Invacare Corp. (1999) Summary page 1.
- K983500: PRO2 Check Oxygen Indicator, Medical Technology Specialists, Inc. (1999) Summary page 1.

## Most influential descendants
- 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 UltraMaxO2 Oxygen Analyzer is a tool used to measure oxygen purity, flow and pressure at the outlet of an oxygen concentrator. The UltraMaxO2 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.

Source page: https://510kreport.com/device/K112402
Methodology: https://510kreport.com/methodology