510(k) · Cleared
ClearedEnvitec Reusable Softip Y SPO2 Sensors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Envitec-Wismar GmbH · DQA Oximeter
Cleared on Jul 17, 2006 as substantially equivalent to K043463 (Envitec-Wismar GmbH, 2005) after a 125-day review. Its family tree reaches back 7 generations to 1994. 4 later devices descend from it.
- Decided
- Jul 17, 2006
- Review
- 125 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K941811 (1994). 31 ancestors in all, the oldest K882609 (1989). 4 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 6 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 5 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 4 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 3 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 2 generations backK032979 Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193TPhilips Medical Systems, Inc. · 2004
- 1 generation backK043463 Envitec Reusable Multi-Site Y SPO2 SensorsEnvitec-Wismar GmbH · 2005
- This deviceK060675 Envitec Reusable Softip Y SPO2 SensorsEnvitec-Wismar GmbH · 2006
- Descendant · cites it directly · 3 of its ownK101690 Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with…Sentec AG · 2010 · Recalled
- Descendant · 2 generations on · 1 of its ownK151329 SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite…Sentec AG · 2015 · Recalled
- Descendant · 2 generations on · 0 of its ownK232516 Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG · 2024
- Descendant · 2 generations on · 0 of its ownK162014 Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small…Bluepoint Medical GmbH & Co. KG · 2017
Most influential descendants
Showing 4 of 4 · See all- K101690Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSentec AG · 2010 · cites it directly3descendants
- K151329SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC…Sentec AG · 2015 · 2 generations on1descendant
- K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG · 2024 · 2 generations on0descendants
- K162014Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2…Bluepoint Medical GmbH & Co. KG · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −6 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −5 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −4 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −3 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −2 | K032979 | Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193T | Philips Medical Systems, Inc. | 2004 | — |
| −1 | K043463 | Envitec Reusable Multi-Site Y SPO2 Sensors | Envitec-Wismar GmbH | 2005 | — |
| 0 (this device) | K060675 | Envitec Reusable Softip Y SPO2 Sensors | Envitec-Wismar GmbH | 2006 | — |
| +1 | K101690 | Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor… | Sentec AG | 2010 | 12 |
| +2 | K151329 | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad… | Sentec AG | 2015 | 9 |
| +2 | K232516 | Sentec Digital Monitoring System (SDMS) tCOM+ | Sentec AG | 2024 | — |
| +2 | K162014 | Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor… | Bluepoint Medical GmbH & Co. KG | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 3 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K043463 | Envitec Reusable Multi-Site Y SPO2 SensorsSummary page 1…ss 11 (3) Predicate Device(s): Substantial Equivalence to: K Number Model Manufacturer K043463 Reusable Multi-site Y SpO2 EnviteC-Wismar GmbH Sensors Reason for Submiss… | 2005 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101690 | Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper Cable | 2010 | 3 |
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 12 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 31 ancestors have a recall of any class.
- Of its descendants, K101690 (Sentec AG, 2010) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
EnviteC Reusable SoftY SP02 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SP02) and pulse rate for adult, pediatric, and infant patients in hospitals, hospital-type facilities, mobile, and home environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060675 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060675: Envitec Reusable Softip Y SPO2 Sensors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060675
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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