510(k) · Cleared
ClearedPRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Salter Labs · CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Cleared on Jul 30, 2026 as substantially equivalent to K112402 (Maxtec, LLC, 2011) after a 93-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Jul 30, 2026
- Review
- 93 days
- Class
- Class II
- Product code
- CCL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K920338 (1992). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK920338 Companion Retrofit Oxygen Concentration IndicatorPuritan Bennett Corp. · 1992
- 3 generations backK984295 Invacare Check O2 Plus Concentrator Analyzer (Check O2 Plus)Invacare Corp. · 1999
- 2 generations backK072469 Digiflo Concentrator AnalyzerDigiflo, Inc. · 2008
- 1 generation backK112402 ULTRAMAXO2 Oxygen AnalyerMaxtec, LLC · 2011
- This deviceK261389 PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter Labs · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K920338 | Companion Retrofit Oxygen Concentration Indicator | Puritan Bennett Corp. | 1992 | — |
| −3 | K984295 | Invacare Check O2 Plus Concentrator Analyzer (Check O2 Plus) | Invacare Corp. | 1999 | — |
| −2 | K072469 | Digiflo Concentrator Analyzer | Digiflo, Inc. | 2008 | — |
| −1 | K112402 | ULTRAMAXO2 Oxygen Analyer | Maxtec, LLC | 2011 | — |
| 0 (this device) | K261389 | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) | Salter Labs | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 K221734 Maxtec MaxO2 ME+pscore 11.7 · 3 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 |
|---|---|---|---|
| * | K112402 | ULTRAMAXO2 Oxygen AnalyerSummary page 6…Class II III. Predicate Device Trade name: UltraMax O2 Oxygen Analyzer 510 (k) Number K112402 Regulation Number: 21 CFR 868.1720 Oxygen gas analyzer Product Code: C… | 2011 |
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 34 years and passes through 5 companies; a new generation was cleared every 8.5 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K112402.
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. 2026, 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 PRO2 Elite Plus Oxygen Analyzer is intended as a tool to be used by qualified personnel to spot-check oxygen concentration, flow, and pressure of a delivered air/oxygen mixture of an oxygen concentrator. The Oxygen 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. The Oxygen Analyzer is not intended for use in continuous monitoring of oxygen delivery to patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261389 · printed Nov 5, 2026
Cite this page
510(k) Report. “K261389: PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K261389
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026