# K973282: Handi Oxygen Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Ceramatec, Inc.
- Decided: Mar 4, 1998 after 183 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 K935370 (1994). 1 ancestor in all.
28 later devices descend from it; 3 cite it directly.
3 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935370: Miniox IA Oxygen Analyzer, Minesafety Appliances Co. (1994) Summary page 1.

## Most influential descendants
- K051857: Veo Multigas Monitor for Pocket PC, Model 400221 (2005), 16 descendants of its own
- K081601: Veo Multigas Monitor for Pocket PC (2008), 12 descendants of its own
- K123043: Irma C02 Model 200101; Irma AX 200601 (2012), 11 descendants of its own
- K023565: Oxicheck (2003), 10 descendants of its own
- K040484: MAXO2+, Model a and AE (2004), 9 descendants of its own

## Indications for use
Purpose: The purpose of the Ceramatec® Handi oxygen analyzer is to monitor oxygen concentration in the patient breathing environment. Function: The Ceramatec® Handi oxygen analyzer measures the oxygen partial pressure of a gas stream, and displays a digital reading of the oxygen concentration of the measured gas on a liquid-crystal display (LCD). Target Patient Population: The target patient population consists of patients who require the oxygen concentration in their environment to be monitored. Environment of Use: The Ceramatec® Handi oxygen analyzer is used in patient breathing environments whose temperatures range from 10 to 40 °C, and whose relative humidity ranged from 0 - 95% (non-condensing). Device Claims: The Ceramatec® Handi oxygen analyzer has the claim of monitoring percent-oxygen concentration in the patient breathing environment.

Source page: https://510kreport.com/device/K973282
Methodology: https://510kreport.com/methodology