510(k) · Cleared
ClearedOxygen Analyzer, Models Aii 20000A, Aii 2000HC, Aii 2000M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Analytical Industries, Inc. · CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Cleared on Apr 5, 2006 as substantially equivalent to K002382 (Analytical Industries, Inc., 2001) after a 119-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Apr 5, 2006
- Review
- 119 days
- Class
- Class II
- Product code
- CCL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002382 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK002382 'All 2000' % Oxygen AnalyzerAnalytical Industries, Inc. · 2001
- This deviceK053407 Oxygen Analyzer, Models Aii 20000A, Aii 2000HC, Aii 2000MAnalytical Industries, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002382 | 'All 2000' % Oxygen Analyzer | Analytical Industries, Inc. | 2001 | — |
| 0 (this device) | K053407 | Oxygen Analyzer, Models Aii 20000A, Aii 2000HC, Aii 2000M | Analytical Industries, Inc. | 2006 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CCL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CCL device
- #1 K261389 PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K002382 | 'All 2000' % Oxygen AnalyzerSummary page 1…Anesthesiology Regulatory Class: I~b Product Code: 73 CCL Predicate Device(s): 510(k) #K002382 Analytical Industries All 2000 Oxygen Analyzer 510(k) #1(000700 Sensidyne Monitor Analyz… | 2001 |
| † | K000700 | Sensidyne Oxygen Analyzer & Sensidyne Oxygen Monitor | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All CCL devicesCCL Analyzer, Gas, Oxygen, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CCL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CCL
Too few CCL 510(k)s in any year since 2007 to give a median.
Recalls per year · CCL
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CCL
2in 2025
MAUDE reports naming product code CCL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 0 | — | 1 | 2 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053407 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053407: Oxygen Analyzer, Models Aii 20000A, Aii 2000HC, Aii 2000M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053407
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026