510(k) · Cleared
ClearedOxicheck
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caradyne, Ltd. · CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Cleared on Mar 28, 2003 as substantially equivalent to K973282 (Ceramatec, Inc., 1998) and 1 other predicate after a 156-day review. Its family tree reaches back 2 generations to 1994. 10 later devices descend from it.
- Decided
- Mar 28, 2003
- Review
- 156 days
- Class
- Class II
- Product code
- CCL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K935370 (1994). 3 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK935370 Miniox IA Oxygen AnalyzerMinesafety Appliances Co. · 1994
- 1 generation backK973282 Handi Oxygen AnalyzerCeramatec, Inc. · 1998
- This deviceK023565 OxicheckCaradyne, Ltd. · 2003
- Descendant · cites it directly · 9 of its ownK040484 MAXO2+, Model a and AEMaxtec, Inc. · 2004
- Descendant · 2 generations on · 7 of its ownK063488 MAXO2 CUMaxtec, Inc. · 2007
- Descendant · 2 generations on · 3 of its ownK122290 Envitec Mysign O Oxygen Measuring DeviceEnvitec-Wismar GmbH · 2013
- Descendant · 3 generations on · 2 of its ownK072845 Precision FlowVapotherm, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 1 of its ownK183687 LifeWindow LW8 LiteDigicare Biomedical Technology, Inc. · 2019
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K040484MAXO2+, Model a and AEMaxtec, Inc. · 2004 · cites it directly9descendants
- K063488MAXO2 CUMaxtec, Inc. · 2007 · 2 generations on7descendants
- K122290Envitec Mysign O Oxygen Measuring DeviceEnvitec-Wismar GmbH · 2013 · 2 generations on3descendants
- K072845Precision FlowVapotherm, Inc. · 2008 · 3 generations on2descendants
- K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc. · 2019 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935370 | Miniox IA Oxygen Analyzer | Minesafety Appliances Co. | 1994 | — |
| −1 | K973282 | Handi Oxygen Analyzer | Ceramatec, Inc. | 1998 | — |
| 0 (this device) | K023565 | Oxicheck | Caradyne, Ltd. | 2003 | — |
| +1 | K040484 | MAXO2+, Model a and AE | Maxtec, Inc. | 2004 | — |
| +2 | K063488 | MAXO2 CU | Maxtec, Inc. | 2007 | — |
| +2 | K122290 | Envitec Mysign O Oxygen Measuring Device | Envitec-Wismar GmbH | 2013 | — |
| +3 | K072845 | Precision Flow | Vapotherm, Inc. | 2008 | 8 |
| +3 | K183687 | LifeWindow LW8 Lite | Digicare Biomedical Technology, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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? (2)
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 |
|---|---|---|---|
| * | K973282 | Handi Oxygen AnalyzerSummary page 1…Oxygen analyzer Classification Name: Analyzer, Gas, Oxygen, gaseous phase Predicate Devices: Ceramatec - Handi - K973282 Caradyne - Criterion 60 - KO00959 Device Description: The OxiCheck is a disposable… | 1998 |
| * | K000959 | Criterion 60 or PM 60 | 2000 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040484 | MAXO2+, Model a and AE | 2004 | 9 |
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 9 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K040484 (Maxtec, Inc., 2004) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K973282.
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 OxiCheck is intended as a tool for use by qualified personnel to check or measure oxygen concentration of a delivered air / oxygen mixture.
The OxiCheck is not intended for use in breathing systems and is not intended for patient monitoring. It is not intended to be used to continuously monitor or confirm oxygen delivery to a patient.
The OxiCheck is intended to be used in hospitals, Sub-acute Institutions, Transport, and Home care.
The OxiCheck is not intended for use in a MRI environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023565 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023565: Oxicheck.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023565
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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