510(k) · Cleared
ClearedCompanion Retrofit Oxygen Concentration Indicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Puritan Bennett Corp. · CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Cleared on Aug 27, 1992 after a 216-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Aug 27, 1992
- Review
- 216 days
- Class
- Class II
- Product code
- CCL
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK920338 Companion Retrofit Oxygen Concentration IndicatorPuritan Bennett Corp. · 1992
- Descendant · cites it directly · 4 of its ownK984295 Invacare Check O2 Plus Concentrator Analyzer (Check O2 Plus)Invacare Corp. · 1999
- Descendant · 2 generations on · 3 of its ownK072469 Digiflo Concentrator AnalyzerDigiflo, Inc. · 2008
- Descendant · 2 generations on · 2 of its ownK112402 ULTRAMAXO2 Oxygen AnalyerMaxtec, LLC · 2011
- Descendant · 3 generations on · 0 of its ownK261389 PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter Labs · 2026
- Descendant · 3 generations on · 0 of its ownK250002 Smart Check O2 (MA0236)Life Spark Medical, LLC · 2025
Most influential descendants
Showing 5 of 5 · See all- K984295Invacare Check O2 Plus Concentrator Analyzer (Check O2 Plus)Invacare Corp. · 1999 · cites it directly4descendants
- K072469Digiflo Concentrator AnalyzerDigiflo, Inc. · 2008 · 2 generations on3descendants
- K112402ULTRAMAXO2 Oxygen AnalyerMaxtec, LLC · 2011 · 2 generations on2descendants
- K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter Labs · 2026 · 3 generations on0descendants
- K250002Smart Check O2 (MA0236)Life Spark Medical, LLC · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K920338 | Companion Retrofit Oxygen Concentration Indicator | Puritan Bennett Corp. | 1992 | — |
| +1 | K984295 | Invacare Check O2 Plus Concentrator Analyzer (Check O2 Plus) | Invacare Corp. | 1999 | — |
| +2 | K072469 | Digiflo Concentrator Analyzer | Digiflo, Inc. | 2008 | — |
| +2 | K112402 | ULTRAMAXO2 Oxygen Analyer | Maxtec, LLC | 2011 | — |
| +3 | K261389 | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) | Salter Labs | 2026 | — |
| +3 | K250002 | Smart Check O2 (MA0236) | Life Spark Medical, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K984295 | Invacare Check O2 Plus Concentrator Analyzer (Check O2 Plus) | 1999 | 4 |
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?
- Of its descendants, K984295 (Invacare Corp., 1999) has gone furthest, with 4 descendants of its own.
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 | — |
https://510kreport.com/device/K920338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K920338: Companion Retrofit Oxygen Concentration Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920338
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026