510(k) · Cleared
ClearedDisposable SpO2 Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Sino-K Medical Technology Co.,Ltd · DQA Oximeter
Cleared on Jan 24, 2020 as substantially equivalent to K181270 (Orantech, Inc., 2018) after a 126-day review. Its family tree reaches back 19 generations to 1994.
- Decided
- Jan 24, 2020
- Review
- 126 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 19 generations to K941811 (1994). 83 ancestors in all, the oldest K863784 (1986). No later device cites it as a predicate yet.
- Root · 19 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 15 generations between
- 3 generations backK111888 Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation · 2011
- 2 generations backK153184 Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd. · 2017
- 1 generation backK181270 Disposable SpO2 Sensors, Reusable SpO2 SensorsOrantech, Inc. · 2018
- This deviceK192608 Disposable SpO2 SensorShenzhen Sino-K Medical Technology Co.,Ltd · 2020
Show all 19 generations
- Root · 19 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 18 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 17 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 16 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 15 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 14 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 13 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 12 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 11 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 10 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 9 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 8 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 7 generations backK040259 Masimo Set Intellivue Pulse Oximeter ModuleMasimo Corp. · 2004
- 6 generations backK041815 LNCS Oximetry SensorsMasimo Corp. · 2004
- 5 generations backK051212 Modification to LNCS Oximetry SensorsMasimo Corporation · 2005 · Recalled
- 4 generations backK101896 Masimo LNCS/M-LNCS Oximetry SensorsMasimo Corporation · 2010
- 3 generations backK111888 Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry SensorsMasimo Corporation · 2011
- 2 generations backK153184 Caremed Reusable & Disposable SPO2 SensorsShenzhen Caremed Medical Technology Co., Ltd. · 2017
- 1 generation backK181270 Disposable SpO2 Sensors, Reusable SpO2 SensorsOrantech, Inc. · 2018
- This deviceK192608 Disposable SpO2 SensorShenzhen Sino-K Medical Technology Co.,Ltd · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −18 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −17 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −16 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −15 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −14 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −13 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −12 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −11 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −10 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −9 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −8 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −7 | K040259 | Masimo Set Intellivue Pulse Oximeter Module | Masimo Corp. | 2004 | — |
| −6 | K041815 | LNCS Oximetry Sensors | Masimo Corp. | 2004 | — |
| −5 | K051212 | Modification to LNCS Oximetry Sensors | Masimo Corporation | 2005 | 5 |
| −4 | K101896 | Masimo LNCS/M-LNCS Oximetry Sensors | Masimo Corporation | 2010 | — |
| −3 | K111888 | Masimo Lnop/LNCS/M-LNCS Multisite-L Oximetry Sensors | Masimo Corporation | 2011 | — |
| −2 | K153184 | Caremed Reusable & Disposable SPO2 Sensors | Shenzhen Caremed Medical Technology Co., Ltd. | 2017 | — |
| −1 | K181270 | Disposable SpO2 Sensors, Reusable SpO2 Sensors | Orantech, Inc. | 2018 | — |
| 0 (this device) | K192608 | Disposable SpO2 Sensor | Shenzhen Sino-K Medical Technology Co.,Ltd | 2020 | — |
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 | 6 | 0 |
| 1999 | 9 | 0 |
| 2000 | 13 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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? (1)
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 |
|---|---|---|---|
| * | K181270 | Disposable SpO2 Sensors, Reusable SpO2 SensorsSummary page 4…meter / DQA Submission type Traditional 510(K) 4. Predicate Device Manufacturer: Orantech Inc. 510 (k) #: K181270 Product Name: Disposable SpO2 Sensors 5. Device Description The proposed device, Disposable SpO… | 2018 |
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 26 years and passes through 10 companies; a new generation was cleared every 6 months on median.
- 6 of the 83 ancestors have a recall of any class.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The Disposable SPO2 Sensor is indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 40 kg at hospital facilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192608 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192608: Disposable SpO2 Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192608
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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