510(k) · Cleared
ClearedInvacare Check O2 Plus Concentrator Analyzer (Check O2 Plus)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invacare Corp. · CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Cleared on Jul 9, 1999 as substantially equivalent to K920338 (Puritan Bennett Corp., 1992) after a 220-day review. Its family tree reaches back 1 generation to 1992. 4 later devices descend from it.
- Decided
- Jul 9, 1999
- Review
- 220 days
- Class
- Class II
- Product code
- CCL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K920338 (1992). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK920338 Companion Retrofit Oxygen Concentration IndicatorPuritan Bennett Corp. · 1992
- This deviceK984295 Invacare Check O2 Plus Concentrator Analyzer (Check O2 Plus)Invacare Corp. · 1999
- Descendant · cites it directly · 3 of its ownK072469 Digiflo Concentrator AnalyzerDigiflo, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK112402 ULTRAMAXO2 Oxygen AnalyerMaxtec, LLC · 2011
- Descendant · 2 generations on · 0 of its ownK261389 PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter Labs · 2026
- Descendant · 2 generations on · 0 of its ownK250002 Smart Check O2 (MA0236)Life Spark Medical, LLC · 2025
Most influential descendants
Showing 4 of 4 · See all- K072469Digiflo Concentrator AnalyzerDigiflo, Inc. · 2008 · cites it directly3descendants
- K112402ULTRAMAXO2 Oxygen AnalyerMaxtec, LLC · 2011 · cites it directly2descendants
- K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter Labs · 2026 · 2 generations on0descendants
- K250002Smart Check O2 (MA0236)Life Spark Medical, LLC · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920338 | Companion Retrofit Oxygen Concentration Indicator | Puritan Bennett Corp. | 1992 | — |
| 0 (this device) | K984295 | Invacare Check O2 Plus Concentrator Analyzer (Check O2 Plus) | Invacare Corp. | 1999 | — |
| +1 | K072469 | Digiflo Concentrator Analyzer | Digiflo, Inc. | 2008 | — |
| +1 | K112402 | ULTRAMAXO2 Oxygen Analyer | Maxtec, LLC | 2011 | — |
| +2 | K261389 | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) | Salter Labs | 2026 | — |
| +2 | K250002 | Smart Check O2 (MA0236) | Life Spark Medical, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K920338 | Companion Retrofit Oxygen Concentration IndicatorSummary page 1…fication Name Oxygen Gas Analyzer Predicate Devices The Invacare Check Oz Plus is substantially equivalent to the Puritan Bennett Corporations’ Model “Companion ROCI (K920338).” Intended Use The Invacare Check 02 Concentrator Analyzer device is a tool for use by service personnel to eva… | 1992 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- Of its descendants, K072469 (Digiflo, Inc., 2008) has gone furthest, with 3 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 | — |
What is it indicated for?
The Invacare Check O2 Concentrator Analyzer device is a tool for use by service personnel to evaluate the output of an oxygen concentrator. Its intended use is to provide information to the service technician regarding oxygen content, flow rate, and pressure, of oxygen produced by an oxygen concentrator. It is not intended to be used by patients who are prescribed oxygen, nor is it intended to continuously monitor or confirm oxygen delivery to patient.…
Read the full statement (169 words)
The Invacare Check O2 Concentrator Analyzer device is a tool for use by service personnel to
evaluate the output of an oxygen concentrator. Its intended use is to provide information to the
service technician regarding oxygen content, flow rate, and pressure, of oxygen produced by an
oxygen concentrator. It is not intended to be used by patients who are prescribed oxygen, nor is it
intended to continuously monitor or confirm oxygen delivery to patient.
The Check O2 has measurement capability in the following ranges:
73% - 95.6% Oxygen Concentration
0 - 6 LPM Flow
0 - 10 PSI Pressure
Accuracy of the Device is:
+ 2% Oxygen Concentration
£.3 L/M Flow (5% of full scale) + 1 digit
+ 2 PSI Full Scale Pressure
0 to 68.95 kPa, + 2% Full Scale
Intended Environment: The Check O2 is intended to be used in an environment where Oxygen
Concentrators are serviced or repaired. This includes Hospitals, Nursing Homes, Extended Care
Facilities, Patient Homes and Respiratory Device Service and Repair Centers.
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/K984295 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984295: Invacare Check O2 Plus Concentrator Analyzer (Check O2 Plus).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984295
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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