510(k) · Cleared
ClearedNellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solaris Medical Technology, Inc. · DQA Oximeter
Cleared on Oct 7, 2010 as substantially equivalent to K993637 (Nellcor Puritan Bennett, Inc., 1999) and 4 other predicates after a 268-day review. Its family tree reaches back 7 generations to 1994. 22 later devices descend from it.
- Decided
- Oct 7, 2010
- Review
- 268 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K941811 (1994). 34 ancestors in all, the oldest K882609 (1989). 22 later devices descend from it, 4 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 backK042306 Philips SP02 Disposable Sensor, Model M1131APhilips Medizin Systeme Boeblingen GmbH · 2004
- This deviceK100077 Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model…Solaris Medical Technology, Inc. · 2010
- Descendant · cites it directly · 14 of its ownK142832 Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc. · 2015
- Descendant · cites it directly · 5 of its ownK153184 Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd. · 2017
- Descendant · 2 generations on · 1 of its ownK242580 Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable…Unimed Medical Supplies, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK202851 Spo2 SensorJkh USA, LLC · 2020
- Descendant · 2 generations on · 1 of its ownK201360 Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd. · 2020
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K142832Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc. · 2015 · cites it directly14descendants
- K153184Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd. · 2017 · cites it directly5descendants
- K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…Unimed Medical Supplies, Inc. · 2025 · 2 generations on1descendant
- K202851Spo2 SensorJkh USA, LLC · 2020 · 2 generations on1descendant
- K201360Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd. · 2020 · 2 generations on1descendant
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 | K042306 | Philips SP02 Disposable Sensor, Model M1131A | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| 0 (this device) | K100077 | Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103 | Solaris Medical Technology, Inc. | 2010 | — |
| +1 | K142832 | Unimed Disposable and Reusable SPO2 Sensors | Unimed Medical Supplies, Inc. | 2015 | — |
| +1 | K153184 | Caremed Reusable & Disposable SPO2 Sensors | Shenzhen Caremed Medical Technology Co., Ltd. | 2017 | — |
| +2 | K242580 | Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger… | Unimed Medical Supplies, Inc. | 2025 | — |
| +2 | K202851 | Spo2 Sensor | Jkh USA, LLC | 2020 | — |
| +2 | K201360 | Reusable and Disposable SpO2 Sensors | Xinkang Medical Instrument Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 6 | 0 |
| 2026 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K993637 | N-395 Pulse Oximeter, with Extended Device ClaimsSummary page 1…Device(s): Substantial Equivalence to: K Number Model Manufaicturer K(993637* Device Name MODEL 2500A Nellcor Puritan Bennett, Inc. Palmsat Pulse… | 1999 |
| * | K050056 | Model 2500A Palmsat Pulse OximeterSummary page 2…Page 2 of 4 K Number Model Manufacturer K050056* Device Name MODEL 2500A Nonin Medical, Inc. Palmsat Pulse Oximeter (wi… | 2005 |
| * | K000822 | Agilentcomponent Monitoring System, Agilent 24/26, Agilent Multi-Measurement Server and…Summary page 2…8000AA Finger Clip Sensor, 7000A, 7000P, 70001 Flexi-Form 11 Disposable sensors specified) K000822* Philips/Agilent component Agilent Technologies, GmbH monitoring system,… | 2000 |
| * | K042306 | Philips SP02 Disposable Sensor, Model M1131ASummary page 2…26 (formerly HP) (with model Ml1 19 1A Reusable SpO2 Sensor specified as accessory) K(042306 Philips Ml 13 1A SpO2 Disposable Philips Medizinsysteme SpO 2 Sensor… | 2004 |
| * | K083705 | Bci WW1020 Pulse Oximeter, Model WW1020Summary page 2…1A SpO2 Disposable Philips Medizinsysteme SpO 2 Sensor Boeblingen GmbH (formerly HP) K083705* BCI WWI1020 SPECTRO2 Pulse Smiths Medical PM, Inc. (formerly Oximeter (wi… | 2009 |
What descends from it? (22)
See all 224 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 34 ancestors have a recall of any class.
- Of its descendants, K142832 (Unimed Medical Supplies, Inc., 2015) has gone furthest, with 14 descendants of its own.
- 11 other devices also cite its predicate K993637.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
When used with a compatible patient monitor or a pulse oximeter device, Solaris Medical Technology, Inc. reusable & disposable SpO2 sensors are intended to be used for continuous, non-invasive functional arterial oxygen saturation (SpO2) and pulse rate monitoring. Solaris Medical Technology, Inc. reusable multi-patient use SpO2 Soft Sensors, reusable multi-patient use SpO2 Finger Sensors, and disposable single patient use SpO2 Soft-finger Sensors are for…
Read the full statement (109 words)
When used with a compatible patient monitor or a pulse oximeter device, Solaris Medical Technology, Inc. reusable & disposable SpO2 sensors are intended to be used for continuous, non-invasive functional arterial oxygen saturation (SpO2) and pulse rate monitoring.
Solaris Medical Technology, Inc. reusable multi-patient use SpO2 Soft Sensors, reusable multi-patient use SpO2 Finger Sensors, and disposable single patient use SpO2 Soft-finger Sensors are for use with adult/pediatric patients weighing greater than 40kg.
Solaris Medical Technology, Inc. disposable single patient use SpO2 Adhesive Sensors are for use with adult patients weighing greater than 40kg, pediatric patients weighing 10 - 40 kg, and infant (non-neonatal) patients weighing 3 - 15 kg.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100077 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100077: Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100077
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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