510(k) · Cleared
ClearedAccu O2 Oxygen Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Medical, Inc. · CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Cleared on May 2, 2018 as substantially equivalent to K040484 (Maxtec, Inc., 2004) after a 138-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- May 2, 2018
- Review
- 138 days
- Class
- Class II
- Product code
- CCL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K935370 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK935370 Miniox IA Oxygen AnalyzerMinesafety Appliances Co. · 1994
- 3 generations backK973282 Handi Oxygen AnalyzerCeramatec, Inc. · 1998
- 2 generations backK023565 OxicheckCaradyne, Ltd. · 2003
- 1 generation backK040484 MAXO2+, Model a and AEMaxtec, Inc. · 2004
- This deviceK173807 Accu O2 Oxygen AnalyzerPrecision Medical, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K935370 | Miniox IA Oxygen Analyzer | Minesafety Appliances Co. | 1994 | — |
| −3 | K973282 | Handi Oxygen Analyzer | Ceramatec, Inc. | 1998 | — |
| −2 | K023565 | Oxicheck | Caradyne, Ltd. | 2003 | — |
| −1 | K040484 | MAXO2+, Model a and AE | Maxtec, Inc. | 2004 | — |
| 0 (this device) | K173807 | Accu O2 Oxygen Analyzer | Precision Medical, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
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 |
|---|---|---|---|
| * | K040484 | MAXO2+, Model a and AESummary page 5…West Salt Lake City, Utah 84119 Classification Name: Analyzer, Gas, Oxygen, Gaseous-Phase Premarket Notification #: K040484 ---------------------------------------------------------------------------------------------------- Referenced Predicate Device;… | 2004 |
| † | K063096 | Precision Oxygen Monitor | 2007 |
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?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 5.1 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K040484.
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. 2018, this device’s year, is highlighted.
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 PM5950 Accu O2 Analyzer is intended as a tool for use by qualified personnel to spot-check or measure oxygen concentration of a delivered air/oxygen mixture. The PM5950 Accu O2 Analyzer is not intended for use in continuous monitoring of oxygen delivery to patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173807 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173807: Accu O2 Oxygen Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173807
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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