510(k) · Cleared
ClearedMysign S Pulse Oximeter, Mysign PC Software (Optional), Softtip Large R-3211-31, Finger Clip F-3211-31
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Envitec-Wismar GmbH · DQA Oximeter
Cleared on May 2, 2014 as substantially equivalent to K070193 (Envitec-Wismar GmbH, 2007) and 2 other predicates after a 217-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- May 2, 2014
- Review
- 217 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K935370 (1994). 18 ancestors in all, the oldest K915699 (1993). No later device cites it as a predicate yet.
- Root · 6 generations backK935370 Miniox IA Oxygen AnalyzerMinesafety Appliances Co. · 1994
- 5 generations backK973282 Handi Oxygen AnalyzerCeramatec, Inc. · 1998
- 4 generations backK023565 OxicheckCaradyne, Ltd. · 2003
- 3 generations backK040484 MAXO2+, Model a and AEMaxtec, Inc. · 2004
- 2 generations backK063488 MAXO2 CUMaxtec, Inc. · 2007
- 1 generation backK122290 Envitec Mysign O Oxygen Measuring DeviceEnvitec-Wismar GmbH · 2013
- This deviceK133064 Mysign S Pulse Oximeter, Mysign PC Software (Optional), Softtip…Envitec-Wismar GmbH · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K935370 | Miniox IA Oxygen Analyzer | Minesafety Appliances Co. | 1994 | — |
| −5 | K973282 | Handi Oxygen Analyzer | Ceramatec, Inc. | 1998 | — |
| −4 | K023565 | Oxicheck | Caradyne, Ltd. | 2003 | — |
| −3 | K040484 | MAXO2+, Model a and AE | Maxtec, Inc. | 2004 | — |
| −2 | K063488 | MAXO2 CU | Maxtec, Inc. | 2007 | — |
| −1 | K122290 | Envitec Mysign O Oxygen Measuring Device | Envitec-Wismar GmbH | 2013 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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 DQA? 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 DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 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 |
|---|---|---|---|
| * | K070193 | Envitec Oxipen Pulse Oximeter and AccessoriesSummary page 1…(3) Predicate Device(s): Substantial Equivalence to: K Number Model Manufacturer K070193 EnviteC OxiPen EnviteC-Wismar GmnbH, a… | 2007 |
| * | K991823 | N-395 Pulse Oximeter, Model N-395Summary page 1…193 EnviteC OxiPen EnviteC-Wismar GmnbH, a Honeywell Company K991823 Nellcor N-395 Philips Medical Systems… | 1999 |
| * | K122290 | Envitec Mysign O Oxygen Measuring DeviceSummary page 1…K991823 Nellcor N-395 Philips Medical Systems (formerly HP) K122290 Envitec MySign PC Software EnviteC-Wismar GmbH, a (listed accessory of MySign 0… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- None of the 18 ancestors has a recall.
- 1 other device also cites its predicate K070193.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, 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 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
MySign® S is a handheld pulse oximeter with accessory sensors indicated for continuous non-invasive monitoring of the functional oxygen saturation of arterial hemoglobin (SP02) and pulse rate for adult and pediatric (excluding neonatal and infant) patients in hospitals, hospital-type facilities, and mobile transport units. For professional use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133064 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133064: Mysign S Pulse Oximeter, Mysign PC Software (Optional), Softtip Large R-3211-31, Finger Clip F-3211-31.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133064
Report an extraction error
Are you the manufacturer?
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