510(k) · Cleared
ClearedPulseox 5500 Finger Device, Pulseox 7500 Wristwatch Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
S.P.O. Medical Equipment, Ltd. · DQA Oximeter
Cleared on Sep 10, 2004 as substantially equivalent to K001085 (Nonin Medical, Inc., 2000) and 3 other predicates after a 228-day review. Its family tree reaches back 4 generations to 1997. 5 later devices descend from it.
- Decided
- Sep 10, 2004
- Review
- 228 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K962603 (1997). 13 ancestors in all, the oldest K863918 (1987). 5 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 3 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 2 generations backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- 1 generation backK992340 Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop…Masimo Corp. · 1999 · Recalled
- This deviceK040178 Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch DeviceS.P.O. Medical Equipment, Ltd. · 2004
- Descendant · cites it directly · 1 of its ownK202483 MyHomeDocMyhomedoc, Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK170181 PrizmaG-Medical Innovations, Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK223785 N9+Nonagon, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK173589 PrizmaG-Medical Innovations, Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK080375 RMX Physiological Data RecorderS.L.P., Ltd. · 2008
Most influential descendants
Showing 5 of 5 · See all- K202483MyHomeDocMyhomedoc, Ltd. · 2021 · cites it directly1descendant
- K170181PrizmaG-Medical Innovations, Ltd. · 2017 · cites it directly1descendant
- K223785N9+Nonagon, Ltd. · 2023 · 2 generations on0descendants
- K173589PrizmaG-Medical Innovations, Ltd. · 2018 · cites it directly0descendants
- K080375RMX Physiological Data RecorderS.L.P., Ltd. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −3 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −2 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| −1 | K992340 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop… | Masimo Corp. | 1999 | 1 |
| 0 (this device) | K040178 | Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch Device | S.P.O. Medical Equipment, Ltd. | 2004 | — |
| +1 | K202483 | MyHomeDoc | Myhomedoc, Ltd. | 2021 | — |
| +1 | K170181 | Prizma | G-Medical Innovations, Ltd. | 2017 | — |
| +2 | K223785 | N9+ | Nonagon, Ltd. | 2023 | — |
| +1 | K173589 | Prizma | G-Medical Innovations, Ltd. | 2018 | — |
| +1 | K080375 | RMX Physiological Data Recorder | S.L.P., Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 3 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 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.
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? (4)
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 |
|---|---|---|---|
| * | K001085 | Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500 | 2000 |
| * | K984570 | Minolta Pulsox-3/Minolta Pulsox-3ISummary page 7…device (manufactured by Nonin Medical Inc., and subject of 5 10(k) document no. KOOt085), the PulSox-3 (manufactured by Minolta and the subject of 510(k) document no. K984570), the Masimo Radical Pulse Oximeter (manufactured by Masimo Corp. and the subject of 510(k) document no. K992340) and to the 310… | 2000 |
| * | K992340 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop -Adt-Adult/Pediatric…Summary page 7…ured by Minolta and the subject of 510(k) document no. K984570), the Masimo Radical Pulse Oximeter (manufactured by Masimo Corp. and the subject of 510(k) document no. K992340) and to the 3100 WristOx Wrist Pulse Oximeter (manufactured by Nonin Medical Inc. and subject of 510(k) document no. K030668).… | 1999 |
| * | K030668 | Model 3100 Wristox Pulse OximeterSummary page 7…rp. and the subject of 510(k) document no. K992340) and to the 3100 WristOx Wrist Pulse Oximeter (manufactured by Nonin Medical Inc. and subject of 510(k) document no. K030668). 11. Technological Characteristics Compared to Predicate Device The technological characteristics, e.g., over… | 2003 |
What descends from it? (5)
4 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 7 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K202483 (Myhomedoc, Ltd., 2021) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K001085.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 SPO PulseOx 5500 Pulse Oximeter is indicated for use for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients in hospitals, medical facilities, home care, transport and sub-acute environment.
The SPO PulseOx 7500 Pulse Oximeter, a small, wrist-worn device, is indicated for use in measuring, displaying and storing functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It may be used for spot checking and/or data collection and recording of adult and pediatric patients in hospitals, medical facilities, ambulatory, sub-acute and sleep study environments.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K040178 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040178: Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040178
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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