510(k) · Cleared
ClearedEnvitec Mysign O Oxygen Measuring Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Envitec-Wismar GmbH · CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Cleared on Jan 23, 2013 as substantially equivalent to K040484 (Maxtec, Inc., 2004) and 2 other predicates after a 177-day review. Its family tree reaches back 5 generations to 1994. 3 later devices descend from it.
- Decided
- Jan 23, 2013
- Review
- 177 days
- Class
- Class II
- Product code
- CCL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K935370 (1994). 9 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK935370 Miniox IA Oxygen AnalyzerMinesafety Appliances Co. · 1994
- 4 generations backK973282 Handi Oxygen AnalyzerCeramatec, Inc. · 1998
- 3 generations backK023565 OxicheckCaradyne, Ltd. · 2003
- 2 generations backK040484 MAXO2+, Model a and AEMaxtec, Inc. · 2004
- 1 generation backK063488 MAXO2 CUMaxtec, Inc. · 2007
- This deviceK122290 Envitec Mysign O Oxygen Measuring DeviceEnvitec-Wismar GmbH · 2013
- Descendant · cites it directly · 1 of its ownK183687 LifeWindow LW8 LiteDigicare Biomedical Technology, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK200434 V20, V20a, AVSM3 SNFMediana Co., Ltd. · 2020 · Recalled
- Descendant · cites it directly · 0 of its ownK133064 Mysign S Pulse Oximeter, Mysign PC Software (Optional), Softtip…Envitec-Wismar GmbH · 2014
Most influential descendants
Showing 3 of 3 · See all- K183687LifeWindow LW8 LiteDigicare Biomedical Technology, Inc. · 2019 · cites it directly1descendant
- K200434V20, V20a, AVSM3 SNFMediana Co., Ltd. · 2020 · 2 generations on0descendants
- K133064Mysign S Pulse Oximeter, Mysign PC Software (Optional), Softtip Large R-3211-31, Finger…Envitec-Wismar GmbH · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K935370 | Miniox IA Oxygen Analyzer | Minesafety Appliances Co. | 1994 | — |
| −4 | K973282 | Handi Oxygen Analyzer | Ceramatec, Inc. | 1998 | — |
| −3 | K023565 | Oxicheck | Caradyne, Ltd. | 2003 | — |
| −2 | K040484 | MAXO2+, Model a and AE | Maxtec, Inc. | 2004 | — |
| −1 | K063488 | MAXO2 CU | Maxtec, Inc. | 2007 | — |
| 0 (this device) | K122290 | Envitec Mysign O Oxygen Measuring Device | Envitec-Wismar GmbH | 2013 | — |
| +1 | K183687 | LifeWindow LW8 Lite | Digicare Biomedical Technology, Inc. | 2019 | — |
| +2 | K200434 | V20, V20a, AVSM3 SNF | Mediana Co., Ltd. | 2020 | 1 |
| +1 | K133064 | Mysign S Pulse Oximeter, Mysign PC Software (Optional), Softtip Large… | Envitec-Wismar GmbH | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040484 | MAXO2+, Model a and AESummary page 1…lass 11 (3) Predicate Device(s): Substantial Equivalence to: K Number Model Manufacturer K040484 Max 02 Plus - Model 0M25 ME Maxtec, Inc. K063488 Max 02 CU Maxtec, Inc.… | 2004 |
| * | K063488 | MAXO2 CUSummary page 1…alence to: K Number Model Manufacturer K040484 Max 02 Plus - Model 0M25 ME Maxtec, Inc. K063488 Max 02 CU Maxtec, Inc. K082655 EnviteC Medical Oxygen Sensors EnviteC-Wismar G… | 2007 |
| * | K082655 | Envitec Medical Oxygen Senors, Models OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106Summary page 1…anufacturer K040484 Max 02 Plus - Model 0M25 ME Maxtec, Inc. K063488 Max 02 CU Maxtec, Inc. K082655 EnviteC Medical Oxygen Sensors EnviteC-Wismar GmbH (including sensor OGMIl 11) R… | 2008 |
What descends from it? (3)
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 19 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K183687 (Digicare Biomedical Technology, Inc., 2019) has gone furthest, with 1 descendant 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. 2013, 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?
This oxygen measuring device MySign® 0 is designed for continuous or spot monitoring of inspired oxygen concentrations in breathing gas.
MySign® 0 can be used for monitoring the breathing gases dispensed by the following devices'
Anaesthesia breathing systems
Respiratory equipment
Infant incubators
Oxygen therapy systems
The system is suitable for use inside hospitals as well as during transport (except by air), emergencies, and artificial respiration provided at home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122290 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122290: Envitec Mysign O Oxygen Measuring Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122290
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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