510(k) · Cleared
ClearedReusable Envitec Finger SPO2 Sensor-HP/Philips Compatible, Models F-2412, F-2414-15, Reusable Envitec Ear SPO2 Sensor
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 24, 2009 as substantially equivalent to K062605 (Philips Medical Systems, 2006) and 2 other predicates after a 154-day review. Its family tree reaches back 9 generations to 1994.
- Decided
- Jul 24, 2009
- Review
- 154 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K941811 (1994). 44 ancestors in all, the oldest K863918 (1987). No later device cites it as a predicate yet.
- Root · 9 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 5 generations between
- 3 generations backK021300 Modification of Philips Component Compact Monitor, Release a.03…Philips Medical Systems · 2002
- 2 generations backK030973 Picosat II SPO2 Pulse Oximetry ModulePhilips Medical Systems · 2003
- 1 generation backK062605 Philips SPO2 Reusable Sensor, Models M1196A and M1196TPhilips Medical Systems · 2006
- This deviceK090438 Reusable Envitec Finger SPO2 Sensor-HP/Philips Compatible, Models…Envitec-Wismar GmbH · 2009
Show all 9 generations
- Root · 9 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 8 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 7 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 6 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 5 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 4 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 3 generations backK021300 Modification of Philips Component Compact Monitor, Release a.03…Philips Medical Systems · 2002
- 2 generations backK030973 Picosat II SPO2 Pulse Oximetry ModulePhilips Medical Systems · 2003
- 1 generation backK062605 Philips SPO2 Reusable Sensor, Models M1196A and M1196TPhilips Medical Systems · 2006
- This deviceK090438 Reusable Envitec Finger SPO2 Sensor-HP/Philips Compatible, Models…Envitec-Wismar GmbH · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −8 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −7 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −6 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −5 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −4 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −3 | K021300 | Modification of Philips Component Compact Monitor, Release a.03, Model M1275B | Philips Medical Systems | 2002 | — |
| −2 | K030973 | Picosat II SPO2 Pulse Oximetry Module | Philips Medical Systems | 2003 | — |
| −1 | K062605 | Philips SPO2 Reusable Sensor, Models M1196A and M1196T | Philips Medical Systems | 2006 | — |
| 0 (this device) | K090438 | Reusable Envitec Finger SPO2 Sensor-HP/Philips Compatible, Models F-2412… | Envitec-Wismar GmbH | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K062605 | Philips SPO2 Reusable Sensor, Models M1196A and M1196TSummary page 1…evice(s): Substantial Equivalence to: K Number Model Manufacturer K062605 Philips Reusable SpO2 Sensors, Philips Medical Systems Models M1196A and… | 2006 |
| * | K030973 | Picosat II SPO2 Pulse Oximetry ModuleSummary page 1…s Models M1196A and M1196T (formerly HP) (Finger Clip Sensors) K030973 Philips picoSAT II SpO2 Pulse Philips Medical Systems Oximetry Module… | 2003 |
| * | K053419 | Konica Minolta Pulsox-300, 300ISummary page 1…Philips picoSAT II SpO2 Pulse Philips Medical Systems Oximetry Module (formerly HP) K053419 PULSOX-300, 300i Konica Minolta Sensing, Inc. Reason for Submission:… | 2006 |
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 15 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 44 ancestors have a recall of any class.
- 4 other devices also cite its predicate K062605.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
EnviteC Reusable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult and pediatric (excluding neonatal and infant) patients in hospitals, hospital-type facilities, mobile units and home environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090438 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090438: Reusable Envitec Finger SPO2 Sensor-HP/Philips Compatible, Models F-2412, F-2414-15, Reusable Envitec Ear SPO2 Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090438
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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