510(k) · Cleared
ClearedMAXO2 CU
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maxtec, Inc. · CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Cleared on Feb 22, 2007 as substantially equivalent to K040484 (Maxtec, Inc., 2004) and 1 other predicate after a 97-day review. Its family tree reaches back 4 generations to 1994. 7 later devices descend from it.
- Decided
- Feb 22, 2007
- Review
- 97 days
- Class
- Class II
- Product code
- CCL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K935370 (1994). 5 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- 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 deviceK063488 MAXO2 CUMaxtec, Inc. · 2007
- Descendant · cites it directly · 3 of its ownK122290 Envitec Mysign O Oxygen Measuring DeviceEnvitec-Wismar GmbH · 2013
- Descendant · cites it directly · 2 of its ownK072845 Precision FlowVapotherm, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 1 of its ownK183687 LifeWindow LW8 LiteDigicare Biomedical Technology, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK254078 HVT 2.0Vapotherm, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK200434 V20, V20a, AVSM3 SNFMediana Co., Ltd. · 2020 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K122290Envitec Mysign O Oxygen Measuring DeviceEnvitec-Wismar GmbH · 2013 · cites it directly3descendants
- K072845Precision FlowVapotherm, Inc. · 2008 · cites it directly2descendants
- K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc. · 2019 · 2 generations on1descendant
- K254078HVT 2.0Vapotherm, Inc. · 2026 · 2 generations on0descendants
- K200434V20, V20a, AVSM3 SNFMediana Co., Ltd. · 2020 · 3 generations on0descendants
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) | K063488 | MAXO2 CU | Maxtec, Inc. | 2007 | — |
| +1 | K122290 | Envitec Mysign O Oxygen Measuring Device | Envitec-Wismar GmbH | 2013 | — |
| +1 | K072845 | Precision Flow | Vapotherm, Inc. | 2008 | 8 |
| +2 | K183687 | LifeWindow LW8 Lite | Digicare Biomedical Technology, Inc. | 2019 | — |
| +2 | K254078 | HVT 2.0 | Vapotherm, Inc. | 2026 | — |
| +3 | K200434 | V20, V20a, AVSM3 SNF | Mediana Co., Ltd. | 2020 | 1 |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040484 | MAXO2+, Model a and AESummary page 1…ification Name: Analyzer, Oxygen, Gaseous-phase Device: MaxO 2 CU Predicate Devices: Maxtec - MAX02 + - K040484 Ceramatec - Handi - K973282 Sensidyne - K010328 The… | 2004 |
| * | K973282 | Handi Oxygen AnalyzerSummary page 1…Device: MaxO 2 CU Predicate Devices: Maxtec - MAX02 + - K040484 Ceramatec - Handi - K973282 Sensidyne - K010328 The MaxO 2 CU is a combination of a continuous use oxygen monitor and… | 1998 |
| Kept off the family tree | K010328 | FDA’s K010328 is Multiple (Izon Dna Blood Collection Kit) Our reading of the summary gave K010328, FDA’s number for Multiple (Izon Dna Blood Collection Kit) (Izon Business Products, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Sensidyne”. Kept off the family tree. Summary page 1…e Devices: Maxtec - MAX02 + - K040484 Ceramatec - Handi - K973282 Sensidyne - K010328 The MaxO 2 CU is a combination of a continuous use oxygen monitor and a venturi oxygen dilution system in one device. An analo… | 2001 |
What descends from it? (7)
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?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K122290 (Envitec-Wismar GmbH, 2013) has gone furthest, with 3 descendants of its own.
- 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. 2007, 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 MaxO 2 CU is a continuous use monitor of oxygen concentration in a patient breathing environment. It may be provided with an oxygen concentration dilution method which could be of a flowmeter, manifold or venturi design, which can deliver set or adjustable FiO 2 oxygen concentrations and flow rates to the patient. It is not intended for use with life supporting systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063488 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063488: MAXO2 CU.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063488
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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