510(k) Report

510(k) · Cleared

Cleared

Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and Reusable SPO2 Sensors

K103584510(k) TraditionalCleared Jun 10, 2011185-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

Shenzhen Envisen Industry Co. Limited · DQA Oximeter

Cleared on Jun 10, 2011 as substantially equivalent to K993637 (Nellcor Puritan Bennett, Inc., 1999) and 8 other predicates after a 185-day review. Its family tree reaches back 9 generations to 1994. 1 of the 75 devices in its family, counting itself, has a Class I recall.

Decided
Jun 10, 2011
Review
185 days
Class
Class II
Product code
DQA
Recalls
None
Predicates
9

Its longest line of descent runs back 9 generations to K941811 (1994). 74 ancestors in all, the oldest K872781 (1987). No later device cites it as a predicate yet. 1 of the 75 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2010: 1 other ancestor2009: 1 other ancestor2008: 1 other ancestor2005: 2 other ancestors2001: 1 other ancestor1999: 6 other ancestors1996: 4 other ancestors1991: 1 other ancestor2007: 3 other ancestors2004: 2 other ancestors2003: 3 other ancestors2002: 2 other ancestors2000: 11 other ancestors1998: 6 other ancestors1997: 5 other ancestors, 1 with a Class I recall11995: 5 other ancestors1990: 3 other ancestors1989: 1 other ancestor1993: 2 other ancestors1992: 3 other ancestors1987: 1 other ancestor1994: 1 other ancestorK941811 · 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) K013199 · Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276B · Philips Medical Systems, Inc. · 2001K021300 · Modification of Philips Component Compact Monitor, Release a.03, Model M1275B · Philips Medical Systems · 2002K030973 · Picosat II SPO2 Pulse Oximetry Module · Philips Medical Systems · 2003K062605 · Philips SPO2 Reusable Sensor, Models M1196A and M1196T · Philips Medical Systems · 2006198519901995200020052010
Other ancestors, by generation 1 generation back: 8 other ancestors2 generations back: 13 other ancestors3 generations back: 13 other ancestors, 1 with a Class I recall14 generations back: 22 other ancestors5 generations back: 5 other ancestors6 generations back: 4 other ancestors K062605 · Philips SPO2 Reusable Sensor, Models M1196A and M1196T · Philips Medical Systems · 2006K030973 · Picosat II SPO2 Pulse Oximetry Module · Philips Medical Systems · 2003K021300 · Modification of Philips Component Compact Monitor, Release a.03, Model M1275B · Philips Medical Systems · 2002K013199 · Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276B · Philips Medical Systems, Inc. · 2001K990972 · 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 · 9 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 5 generations between
  3. 3 generations backK021300 Modification of Philips Component Compact Monitor, Release a.03…Philips Medical Systems · 2002
  4. 2 generations backK030973 Picosat II SPO2 Pulse Oximetry ModulePhilips Medical Systems · 2003
  5. 1 generation backK062605 Philips SPO2 Reusable Sensor, Models M1196A and M1196TPhilips Medical Systems · 2006
  6. This deviceK103584 Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda…Shenzhen Envisen Industry Co. Limited · 2011
Show all 9 generations
  1. Root · 9 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 8 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 7 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 6 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 5 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 4 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
  7. 3 generations backK021300 Modification of Philips Component Compact Monitor, Release a.03…Philips Medical Systems · 2002
  8. 2 generations backK030973 Picosat II SPO2 Pulse Oximetry ModulePhilips Medical Systems · 2003
  9. 1 generation backK062605 Philips SPO2 Reusable Sensor, Models M1196A and M1196TPhilips Medical Systems · 2006
  10. This deviceK103584 Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda…Shenzhen Envisen Industry Co. Limited · 2011

Class I recalls in this family

  • K970209 Capnocheck Plus3 generations back · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−8K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−7K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−6K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−5K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−4K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model…Philips Medical Systems, Inc.2001—
−3K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275BPhilips Medical Systems2002—
−2K030973Picosat II SPO2 Pulse Oximetry ModulePhilips Medical Systems2003—
−1K062605Philips SPO2 Reusable Sensor, Models M1196A and M1196TPhilips Medical Systems2006—
0 (this device)K103584Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible…Shenzhen Envisen Industry Co. Limited2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
198910
199030
199110
199230
199320
199410
199550
199640
199751
199860
199960
2000110
200110
200220
200330
200420
200520
200730
200810
200910
201010
FIG. 1 — Lineage of K103584, 1994–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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.

1 device in this family has a Class I recall. 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? (9)

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
*K993637N-395 Pulse Oximeter, with Extended Device Claims
Summary page 1
…Class: Class II (3) Predicate Device(s): 510(k) Device Manufacturer K(993637 N-395 Pulse Oximeter Nellcor Puritan Bennett, Inc. K(052186 Nellcor Oximax pulse oximetery…
Nellcor Puritan Bennett, Inc.19991
*K052186Nellcor Oximax Pulse Oximetry Sensons (Max-a, Max-AL, Max-N, Max-I, Max-P
Summary page 1
…510(k) Device Manufacturer K(993637 N-395 Pulse Oximeter Nellcor Puritan Bennett, Inc. K(052186 Nellcor Oximax pulse oximetery Nelicor Puritan Bennett, Inc. sensors K093853 Si…
Nellcor Puritan Bennett, Inc.2005—
*K093853Single-Patient Use Disposable Sensor Series
Summary page 1
…Nellcor Puritan Bennett, Inc. K(052186 Nellcor Oximax pulse oximetery Nelicor Puritan Bennett, Inc. sensors K093853 Single-patient use disposable Nonin Medical, Inc. sensor series K080255 MODEL…
Nonin Medical, Inc.2010—
*K080255Nonin Medical, Inc., Model 7500 Digital Pulse Oximeter
Summary page 1
…Inc. sensors K093853 Single-patient use disposable Nonin Medical, Inc. sensor series K080255 MODEL 7500A Palmsat Pulse Nonin Medical, Inc. Oximeter K062605 Philips Sp…
Nonin Medical, Inc.2008—
*K062605Philips SPO2 Reusable Sensor, Models M1196A and M1196T
Summary page 1
…Inc. sensor series K080255 MODEL 7500A Palmsat Pulse Nonin Medical, Inc. Oximeter K062605 Philips SpO2 Reusable Sensor, Philips Medical Systems Model M1196A and M1196T 1(08…
Philips Medical Systems2006—
*K083705Bci WW1020 Pulse Oximeter, Model WW1020
Summary page 1
…Oximeter K062605 Philips SpO2 Reusable Sensor, Philips Medical Systems Model M1196A and M1196T 1(083705 BCI WW1020 SPECTRO2 Pulse Smiths Medical PM, Inc. Oximeter (forme…
Smiths Medical Pm, Inc.2009—
*K910770504US Pulse Oximeter
Summary page 1
…1(083705 BCI WW1020 SPECTRO2 Pulse Smiths Medical PM, Inc. Oximeter (formerly SIMS BCI) K910770 CSI 504-US Pulse Oximeter Criticare Systems, Inc. K962127 Ohmeda 3800 Pulse Oximeter GE He…
Criticare Systems, Inc.1991—
*K962127Ohmeda 3800 Pulse Oximeter
Summary page 1
…Oximeter (formerly SIMS BCI) K910770 CSI 504-US Pulse Oximeter Criticare Systems, Inc. K962127 Ohmeda 3800 Pulse Oximeter GE Healthcare Finland Oy (for…
Ohmeda Medical1996—
*K010463Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessoires
Summary page 1
…962127 Ohmeda 3800 Pulse Oximeter GE Healthcare Finland Oy (formerly Ohmeda Medical) K010463 Datex-Ohmeda Oxygen GE Healthcare Finland Oy Saturation Module, M-OSAT and (for…
Datex-Ohmeda, Inc.20011

Also cleared against K993637: 11 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K970209Capnocheck PlusBci Intl., Inc. · 1997 · 3 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
  • 8 of the 74 ancestors have a recall of any class; 1 has a Class I recall.
  • 11 other devices also cite its predicate K993637.

How does its category compare?

All DQA devices

DQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

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?

Envisen Disposable and Reusable Oximeter Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SP0z) and pulse rate for patients in hospitals, hospital-type facilities, mobile, and home environments.

Indications for use as stated in the FDA summary.

Also cleared against K993637

11 other devices cite the same predicate.

  • K211138Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse…Stryker Sustainability Solutions · 2022
  • K100077Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103Solaris Medical Technology, Inc. · 2010
  • K092549Oxiprobe, Models BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600PBio Medical Technologies Co., Ltd. · 2009
  • K061931Solaris Compatible Reusable Adult SPO2 Finger Sensors, Models S100A-090103 and 300103, S200A-090101 and 300101Solaris Medical Technology, Inc. · 2007
  • K052544Pulse Oximeter Adapter CablesAmerican I.V. Products, Inc. · 2006
  • K033973Oxisensor II Recycled Sensor and Oximax Recycled SensorNellcor Puritan Bennett, Inc. · 2004

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/K103584 · printed Nov 4, 2026

Cite this page

510(k) Report. “K103584: Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and Reusable 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/K103584

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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