# K072469: Digiflo Concentrator Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Digiflo, Inc.
- Decided: Jan 3, 2008 after 121 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: 2 generations back to K920338 (1992). 3 ancestors in all.
3 later devices descend from it; 1 cites 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)
- 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
- 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 DigiFLO Concentrator ANALYZER is a tool used by service personnel to measure Oxygen purity, Flow at the outlet of an oxygen concentrator. Also, it measures gas pressure inside and at the outlet of 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 a patient. The DigiFLO Concentrator 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/K072469
Methodology: https://510kreport.com/methodology