510(k) · Cleared
ClearedUnimed Disposable and Reusable SPO2 Sensors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unimed Medical Supplies, Inc. · DQA Oximeter
Cleared on Feb 6, 2015 as substantially equivalent to K100077 (Solaris Medical Technology, Inc., 2010) and 2 other predicates after a 129-day review. Its family tree reaches back 17 generations to 1994. 14 later devices descend from it.
- Decided
- Feb 6, 2015
- Review
- 129 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 17 generations to K941811 (1994). 85 ancestors in all, the oldest K863784 (1986). 14 later devices descend from it, 10 citing it directly.
- Root · 17 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 13 generations between
- 3 generations backK051212 Modification to LNCS Oximetry SensorsMasimo Corporation · 2005 · Recalled
- 2 generations backK101896 Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation · 2010
- 1 generation backK111888 Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation · 2011
- This deviceK142832 Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK242580 Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable…Unimed Medical Supplies, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK202851 Spo2 SensorJkh USA, LLC · 2020
- Descendant · cites it directly · 1 of its ownK201360 Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK191279 Disposable SpO2 SensorShenzhen Caremed Medical Technology Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK260931 Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc. · 2026
Show all 17 generations
- Root · 17 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 16 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 15 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 14 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 13 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 12 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 11 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 10 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 9 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 8 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 7 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 6 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 5 generations backK040259 Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004
- 4 generations backK041815 LNCS Oximetry SensorsMasimo Corp. · 2004
- 3 generations backK051212 Modification to LNCS Oximetry SensorsMasimo Corporation · 2005 · Recalled
- 2 generations backK101896 Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation · 2010
- 1 generation backK111888 Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation · 2011
- This deviceK142832 Unimed Disposable and Reusable SPO2 SensorsUnimed Medical Supplies, Inc. · 2015
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K242580Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2…Unimed Medical Supplies, Inc. · 2025 · cites it directly1descendant
- K202851Spo2 SensorJkh USA, LLC · 2020 · cites it directly1descendant
- K201360Reusable and Disposable SpO2 SensorsXinkang Medical Instrument Co., Ltd. · 2020 · cites it directly1descendant
- K191279Disposable SpO2 SensorShenzhen Caremed Medical Technology Co., Ltd. · 2019 · cites it directly1descendant
- K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −16 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −15 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −14 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −13 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −12 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −11 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −10 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −9 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −8 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −7 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −6 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −5 | K040259 | Masimo Set Intellivue Pulse Oximeter Module | Masimo Corp. | 2004 | — |
| −4 | K041815 | LNCS Oximetry Sensors | Masimo Corp. | 2004 | — |
| −3 | K051212 | Modification to LNCS Oximetry Sensors | Masimo Corporation | 2005 | 5 |
| −2 | K101896 | Masimo LNCS/M-LNCS Oximetry Sensors | Masimo Corporation | 2010 | — |
| −1 | K111888 | Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry Sensors | Masimo Corporation | 2011 | — |
| 0 (this device) | K142832 | Unimed Disposable and Reusable SPO2 Sensors | Unimed Medical Supplies, Inc. | 2015 | — |
| +1 | K242580 | Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger… | Unimed Medical Supplies, Inc. | 2025 | — |
| +1 | K202851 | Spo2 Sensor | Jkh USA, LLC | 2020 | — |
| +1 | K201360 | Reusable and Disposable SpO2 Sensors | Xinkang Medical Instrument Co., Ltd. | 2020 | — |
| +1 | K191279 | Disposable SpO2 Sensor | Shenzhen Caremed Medical Technology Co., Ltd. | 2019 | — |
| +2 | K260931 | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) | Unimed Medical Supplies, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 9 | 0 |
| 2000 | 14 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 6 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K100077 | Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103Summary page 4…Trade Name/model Submitter Solaris Medical Technology, Inc. Solaris Medical Technology, K100077 Reusable & Disposable SPO2 Sensors Inc. K111888 Masimo LNOP/M-LNCS/LNCS… | 2010 |
| * | K111888 | Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsSummary page 4…Solaris Medical Technology, Inc. Solaris Medical Technology, K100077 Reusable & Disposable SPO2 Sensors Inc. K111888 Masimo LNOP/M-LNCS/LNCS Masimo Corporation Unimed Disposable and Reusable SPO2 Sen… | 2011 |
| * | K082546 | Reusable Ohmeda (U410-02), Datex (U410-09) Compatable Adult Finger Clip Sensor, Phillips…Summary page 5…Road, Shekou, Shenzhen, China 518067 Tel: 86 755 26695165 Fax: 86 755 26697984 Website: www.unimed.cn Email: [email protected] Multisite-L Oximetry Sensors K082546 Unimed compatible oximeter sensors Unimed Medical supplies Inc 7. Device description The Unimed Disposab… | 2008 |
What descends from it? (14)
See all 1410 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242580 | Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2… | 2025 | 1 |
| K202851 | Spo2 Sensor | 2020 | 1 |
| K201360 | Reusable and Disposable SpO2 Sensors | 2020 | 1 |
| K191279 | Disposable SpO2 Sensor | 2019 | 1 |
| K251696 | Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2… | 2025 | 0 |
| K251691 | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08… | 2025 | 0 |
| K251695 | Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06… | 2025 | 0 |
| K251693 | Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75… | 2025 | 0 |
| K191420 | Reusable SpO2 Sensor | 2019 | 0 |
| K173045 | Oximeter | 2018 | 0 |
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 21 years and passes through 8 companies; a new generation was cleared every 5 months on median.
- 6 of the 85 ancestors have a recall of any class.
- Of its descendants, K242580 (Unimed Medical Supplies, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K100077.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Unimed Disposable and Reusable SPO2 Sensors are indicated for continuous non-invasive monitoring of functional
oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 40kg,
pediatric patients weighing 10 -50 kg, and neonatal patients weighing no less than 3 Kg.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142832 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142832: Unimed Disposable and Reusable SPO2 Sensors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142832
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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