# K053407: Oxygen Analyzer, Models Aii 20000A, Aii 2000HC, Aii 2000M

- Pathway: 510(k) (Traditional)
- Applicant: Analytical Industries, Inc.
- Decided: Apr 5, 2006 after 119 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 K002382 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002382: 'All 2000' % Oxygen Analyzer, Analytical Industries, Inc. (2001) Summary page 1.

## Indications for use
The Analytical Industries Inc. AII 2000 Series Oxygen Analyzers & Monitors are intended to measure and display the concentration of oxygen in breathing gas mixtures. The intended use is only to verify, spot check or continuously monitor, oxygen concentrations in circumstances where the oxygen concentration is controlled and set by other medical devices such as oxygen/air blenders, flow meters or other control devices.

Source page: https://510kreport.com/device/K053407
Methodology: https://510kreport.com/methodology