510(k) Report

510(k) · Cleared

Cleared

Envitec Reusable Multi-Site Y SPO2 Sensors

K043463510(k) TraditionalCleared Feb 11, 200558-day reviewClass II21 CFR 870.2700

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Envitec-Wismar GmbH · DQA Oximeter

Cleared on Feb 11, 2005 as substantially equivalent to K944760 (Nellcor, Inc., 1994) and 7 other predicates after a 58-day review. Its family tree reaches back 6 generations to 1994. 5 later devices descend from it.

Decided
Feb 11, 2005
Review
58 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
8

Its longest line of descent runs back 6 generations to K941811 (1994). 30 ancestors in all, the oldest K882609 (1989). 5 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2000: 2 other ancestors1996: 3 other ancestors1994: 2 other ancestors1991: 2 other ancestors1989: 3 other ancestors1999: 1 other ancestor1998: 4 other ancestors1993: 1 other ancestor1990: 1 other ancestor1997: 2 other ancestors1995: 1 other ancestor1992: 1 other ancestor2006: 1 descendant cleared2010: 1 descendant cleared2024: 1 descendant cleared2017: 1 descendant cleared2015: 1 descendant clearedK941811 · HP M1175A, M1176A, Component Monitoring System · Hewlett-Packard Co. · 1994K960934 · HP M1205A Omnicare Component Monitor System Model 24 · Hewlett-Packard Co. · 1996×3: 3 generations cleared close together, K981376 (1999), K990125 (1999), K990972 (1999) K032979 · Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193T · Philips Medical Systems, Inc. · 20041990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 5 other ancestors3 generations back: 6 other ancestors4 generations back: 2 other ancestors5 generations back: 4 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 3 descendants K032979 · Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193T · Philips Medical Systems, Inc. · 2004K990972 · HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia Multi-Measurement Server and Compact Portable T · Hewlett-Packard GmbH · 1999K990125 · HP Viridia Component Monitoring System, Model Rev. K · Hewlett-Packard GmbH · 1999K981376 · Hewlett-Packard M1205A Viridia 24 CT · Hewlett-Packard Co. · 1999K960934 · HP M1205A Omnicare Component Monitor System Model 24 · Hewlett-Packard Co. · 1996K941811 · HP M1175A, M1176A, Component Monitoring System · Hewlett-Packard Co. · 1994−50
  1. Root · 6 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 5 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 4 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 3 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 2 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 1 generation backK032979 Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193TPhilips Medical Systems, Inc. · 2004
  7. This deviceK043463 Envitec Reusable Multi-Site Y SPO2 SensorsEnvitec-Wismar GmbH · 2005
  8. Descendant · cites it directly · 4 of its ownK060675 Envitec Reusable Softip Y SPO2 SensorsEnvitec-Wismar GmbH · 2006
  9. Descendant · 2 generations on · 3 of its ownK101690 Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with…Sentec AG · 2010 · Recalled
  10. Descendant · 3 generations on · 1 of its ownK151329 SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite…Sentec AG · 2015 · Recalled
  11. Descendant · 3 generations on · 0 of its ownK232516 Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG · 2024
  12. Descendant · 3 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 5 of 5 · See all
  • K060675Envitec Reusable Softip Y SPO2 SensorsEnvitec-Wismar GmbH · 2006 · cites it directly4descendants
  • K101690Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSentec AG · 2010 · 2 generations on3descendants
  • K151329SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC…Sentec AG · 2015 · 3 generations on1descendant
  • K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG · 2024 · 3 generations on0descendants
  • K162014Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2…Bluepoint Medical GmbH & Co. KG · 2017 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−5K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−4K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−3K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−2K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−1K032979Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193TPhilips Medical Systems, Inc.2004—
0 (this device)K043463Envitec Reusable Multi-Site Y SPO2 SensorsEnvitec-Wismar GmbH2005—
+1K060675Envitec Reusable Softip Y SPO2 SensorsEnvitec-Wismar GmbH2006—
+2K101690Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor…Sentec AG201012
+3K151329SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad…Sentec AG20159
+3K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG2024—
+3K162014Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor…Bluepoint Medical GmbH & Co. KG2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198930
199010
199120
199210
199310
199420
199510
199630
199720
199840
199910
200020
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201010
201510
201710
202410
FIG. 1 — Lineage of K043463, 1994–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (8)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K944760Dura-Y Oxygen Transducer, Ear Clip
Summary page 1
…(3) Predicate Device(s): Substantial Equivalence to: K Number Model Manufacturer K944760 Nellcor Dura-Y Oxygen Nellcor Puritan Bennett, Inc. Transducer, Ear Clip…
Nellcor, Inc.1994—
*K962127Ohmeda 3800 Pulse Oximeter
Summary page 1
…facturer K944760 Nellcor Dura-Y Oxygen Nellcor Puritan Bennett, Inc. Transducer, Ear Clip K962127 Ohmeda 3800 Pulse Oximeter Datex-Ohmeda, Inc. K893877 Biochem 3100 Oximeter…
Ohmeda Medical1996—
*K893877Biochem 3100 Oximeter
Summary page 1
…ritan Bennett, Inc. Transducer, Ear Clip K962127 Ohmeda 3800 Pulse Oximeter Datex-Ohmeda, Inc. K893877 Biochem 3100 Oximeter BCI-Biochem International, Inc. K(910770 CSI 504-US Pulse Oxim…
Biochem International, Inc.1989—
*K910770504US Pulse Oximeter
Summary page 1
…meda 3800 Pulse Oximeter Datex-Ohmeda, Inc. K893877 Biochem 3100 Oximeter BCI-Biochem International, Inc. K(910770 CSI 504-US Pulse Oximeter CSI-Criticare Systems, Inc. K010463 Datex-Ohmeda S15 Oxygen…
Criticare Systems, Inc.1991—
*K010463Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessoires
Summary page 1
…3100 Oximeter BCI-Biochem International, Inc. K(910770 CSI 504-US Pulse Oximeter CSI-Criticare Systems, Inc. K010463 Datex-Ohmeda S15 Oxygen Datex-Ohmeda, Inc. Saturation Module, M-OSAT and…
Datex-Ohmeda, Inc.20011
*K032979Philips SPO2 Reusable Sensors, Model Nos. M1191T, M1192T, and M1193T
Summary page 1
…x-Ohmeda S15 Oxygen Datex-Ohmeda, Inc. Saturation Module, M-OSAT and Accessories K032979 Philips Reusable SpO2 Sensors Philips Medizin Ayatemne…
Philips Medical Systems, Inc.2004—
*K890033Model 8700 Pulse Oximeter
Summary page 1
…13beblingen GmnbH (farrnedy HP) K890033 Model 8700 Pulse Oximeter Nonin Medical, Inc. K993979 Model 2001MARSpO2 Pulse…
Nonin Medical, Inc.1989—
*K993979MARSPO2, Model 2001
Summary page 1
…HP) K890033 Model 8700 Pulse Oximeter Nonin Medical, Inc. K993979 Model 2001MARSpO2 Pulse Novametrix Medical Systems, Oximeter…
Novametrix Medical Systems, Inc.20001

Also cleared against K944760: 2 other devices →

What descends from it? (5)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K060675Envitec Reusable Softip Y SPO2 SensorsEnvitec-Wismar GmbH20064

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 11 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
  • 3 of the 30 ancestors have a recall of any class.
  • Of its descendants, K060675 (Envitec-Wismar GmbH, 2006) has gone furthest, with 4 descendants of its own.
  • 2 other devices also cite its predicate K944760.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQA

15in 2025

2007: 202008: 222009: 352010: 292011: 152012: 142013: 152014: 112015: 132016: 142017: 92018: 182019: 192020: 152021: 102022: 202023: 132024: 142025: 152026 (partial year): 8
2007high 35 (2009) · low 9 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQA

182in 2025

2007: 122 days median2008: 97 days median2009: 117 days median2010: 127 days median2011: 195 days median2012: 120 days median2013: 182 days median2014: 175 days median2015: 158 days median2016: 246 days median2017: 200 days median2018: 260 days median2019: 158 days median2020: 126 days median2021: 174 days median2022: 265 days median2023: 317 days median2024: 285 days median2025: 182 days median2026 (partial year): 187 days median
2007high 317 (2023) · low 97 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQA

3in 2024

2007: 62008: 52009: 292010: 42011: 12014: 22015: 12018: 322024: 3
2007high 32 (2018) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DQA

399in 2025

2007: 3252008: 3122009: 2812010: 1852011: 1642012: 3222013: 4682014: 1,1242015: 2,0822016: 1,7752017: 1,1902018: 6942019: 5482020: 4262021: 5532022: 4782023: 3922024: 5452025: 399
2007high 2,082 (2015) · low 164 (2011)2025

MAUDE reports naming product code DQA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007201226325
200822975312
20093511729281
2010291274185
2011151951164
2012141200322
2013151820468
20141117521,124
20151315812,082
20161424601,775
2017920001,190
20181826032694
2019191580548
2020151260426
2021101740553
2022202650478
2023133170392
2024142853545
2025151820399
202681870—

What is it indicated for?

EnviteC Reusable Multi-site Y Sp0 2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate for adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

Not recommended for use on the ear.

Indications for use as stated in the FDA summary.

Also cleared against K944760

2 other devices cite the same predicate.

  • K042675Flexi-Stat SP02 Ear SensorElekon Industries U.S.A., Inc. · 2004
  • K012992Masimo Set Radical Pulse Oximeter with Satshare and Masimo Series of Sensors and CablesMasimo Corp. · 2001

More from Envitec-Wismar GmbH

9 FDA decisions under this applicant name. See the company

  • K133064Mysign S Pulse Oximeter, Mysign PC Software (Optional), Softtip Large R-3211-31, Finger Clip F-3211-31Envitec-Wismar GmbH · 2014
  • K122290Envitec Mysign O Oxygen Measuring DeviceEnvitec-Wismar GmbH · 2013
  • K102270Envitec Reusable SPO2 Sensors Type Nihon-KohdenEnvitec-Wismar GmbH · 2011
  • K090438Reusable Envitec Finger SPO2 Sensor-HP/Philips Compatible, Models F-2412, F-2414-15, Reusable Envitec Ear…Envitec-Wismar GmbH · 2009
  • K082655Envitec Medical Oxygen Senors, Models OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106Envitec-Wismar GmbH · 2008

Recent decisions in DQA

The DQA category page

  • K260490Ninenovo Blood Oxygen Ring…Shenzhen Ninenovo Technology Limited · 2026
  • K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbH · 2026
  • K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd. · 2026
  • K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor…Philips Medizin Systeme · 2026
  • K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc. · 2026

https://510kreport.com/device/K043463 · printed Nov 4, 2026

Cite this page

510(k) Report. “K043463: Envitec Reusable Multi-Site Y SPO2 Sensors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043463

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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