510(k) · Cleared
ClearedHandheld Pulse Oximeter, Model SP-20
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Creative Industry Co., Ltd. · DQA Oximeter
Cleared on Nov 13, 2018 as substantially equivalent to K123711 (Shenzhen Creative Industry Co., Ltd., 2013) and 1 other predicate after a 424-day review. Its family tree reaches back 12 generations to 1994. 1 of the 124 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Nov 13, 2018
- Review
- 424 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K941811 (1994). 120 ancestors in all, the oldest K842616 (1984). 3 later devices descend from it, 1 citing it directly. 1 of the 124 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 8 generations between
- 3 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 2 generations backK053234 PM-9000 Express Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · Recalled
- 1 generation backK123711 Patient MonitorShenzhen Creative Industry Co., Ltd. · 2013
- This deviceK172792 Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd. · 2018
- Descendant · cites it directly · 2 of its ownK201468 Pulse OximeterShenzhen Creative Industry Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK213431 Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK212300 Pulse OximeterShenzhen Mericonn Technology Co., Ltd. · 2022
Show all 12 generations
- Root · 12 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 11 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 10 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 9 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 8 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 7 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 6 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 5 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 4 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 3 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 2 generations backK053234 PM-9000 Express Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · Recalled
- 1 generation backK123711 Patient MonitorShenzhen Creative Industry Co., Ltd. · 2013
- This deviceK172792 Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd. · 2018
Class I recalls in this family
- K970209 Capnocheck Plus6 generations back · 1997
Most influential descendants
Showing 3 of 3 · See all- K201468Pulse OximeterShenzhen Creative Industry Co., Ltd. · 2021 · cites it directly2descendants
- K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd. · 2023 · 2 generations on0descendants
- K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −11 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −10 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −9 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −8 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −7 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −6 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −5 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −4 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −3 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −2 | K053234 | PM-9000 Express Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | 1 |
| −1 | K123711 | Patient Monitor | Shenzhen Creative Industry Co., Ltd. | 2013 | — |
| 0 (this device) | K172792 | Handheld Pulse Oximeter, Model SP-20 | Shenzhen Creative Industry Co., Ltd. | 2018 | — |
| +1 | K201468 | Pulse Oximeter | Shenzhen Creative Industry Co., Ltd. | 2021 | — |
| +2 | K213431 | Handheld Pulse Oximeter | Shenzhen Witleaf Medical Electronics Co., Ltd. | 2023 | — |
| +2 | K212300 | Pulse Oximeter | Shenzhen Mericonn Technology Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 4 | 0 |
| 1992 | 6 | 0 |
| 1993 | 5 | 0 |
| 1994 | 6 | 0 |
| 1995 | 9 | 0 |
| 1996 | 7 | 0 |
| 1997 | 9 | 1 |
| 1998 | 11 | 0 |
| 1999 | 11 | 0 |
| 2000 | 13 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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.
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 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? (2)
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 |
|---|---|---|---|
| * | K123711 | Patient MonitorSummary page 5…510(k) Number Shenzhen Creative PATIENT MONITOR, UP-7000 K123711 Industry Co., Ltd Shenzhen Mindray Bio- PM-50 PULSE OXIMETER K052693 Medical Electronics… | 2013 |
| * | K052693 | PM-50 Pulse OximeterSummary page 5…zhen Creative PATIENT MONITOR, UP-7000 K123711 Industry Co., Ltd Shenzhen Mindray Bio- PM-50 PULSE OXIMETER K052693 Medical Electronics Co., Ltd 4. Classifications Names & Citations: DQA, SpO2; FLL, Temperature; 5. Descriptio… | 2006 |
| † | K063641 | PC-60, Non-Invasivepulse Oximeter | 2007 |
| † | K111463 | Valeo VT-601 Series IR Thermometer | 2012 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201468 | Pulse Oximeter | 2021 | 2 |
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 · 6 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 18 of the 120 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K201468 (Shenzhen Creative Industry Co., Ltd., 2021) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K123711.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Handheld Pulse Oximeter is intended for measuring and displaying the pulse rate, functional oxygen saturation
(SpO2) and temperature (optional). It is intended for spot checking and recording of SpO2, pulse rate and temperature of
adult and pediatric patients in clinical institutions and homes. The Handheld Pulse Oximeter is not intended for active
continuous monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172792 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172792: Handheld Pulse Oximeter, Model SP-20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172792
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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