510(k) · Cleared
ClearedColin Press Mate, Model BP S510
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omron Healthcare, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on May 9, 2007 after a 148-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 28 later devices descend from it.
- Decided
- May 9, 2007
- Review
- 148 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 0
28 later devices descend from it, 2 citing it directly.
- This deviceK063690 Colin Press Mate, Model BP S510Omron Healthcare, Inc. · 2007
- Descendant · cites it directly · 27 of its ownK082812 Omron Model HBP-2070 Vital Signs MonitorOmron Healthcare, Inc. · 2008
- Descendant · 2 generations on · 24 of its ownK112478 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 20 of its ownK122036 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 19 of its ownK130709 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2013
- Descendant · 4 generations on · 18 of its ownK133586 Visi Mobile Monitioring SystemSotera Wireless, Inc. · 2013
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K082812Omron Model HBP-2070 Vital Signs MonitorOmron Healthcare, Inc. · 2008 · cites it directly27descendants
- K112478Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · 2 generations on24descendants
- K122036Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · 3 generations on20descendants
- K130709Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2013 · 3 generations on19descendants
- K133586Visi Mobile Monitioring SystemSotera Wireless, Inc. · 2013 · 4 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063690 | Colin Press Mate, Model BP S510 | Omron Healthcare, Inc. | 2007 | — |
| +1 | K082812 | Omron Model HBP-2070 Vital Signs Monitor | Omron Healthcare, Inc. | 2008 | — |
| +2 | K112478 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2012 | 2 |
| +3 | K122036 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2012 | 2 |
| +3 | K130709 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2013 | — |
| +4 | K133586 | Visi Mobile Monitioring System | Sotera Wireless, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 6 | 0 |
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MHX? 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 MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (28)
See all 282 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?
- Of its descendants, K082812 (Omron Healthcare, Inc., 2008) has gone furthest, with 27 descendants of its own.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, 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 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
The Colin Press Mate, Model BP S510 is intended to be used to monitor electrocardiography (ECU), heart rate (HR), noninvasive blood pressure (systolic, diastolic and mean arterial pressures) (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), respiration (RR), body temperature (Temp), invasive blood pressure (IBP) and capnography (EtCO 2 and InCO 2 ). The intended patient populations are: adults and pediatrics of at least 14 years of…
Read the full statement (157 words)
The Colin Press Mate, Model BP S510 is intended to be used to monitor electrocardiography (ECU), heart rate (HR), noninvasive blood pressure (systolic, diastolic and mean arterial pressures) (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), respiration (RR), body temperature (Temp), invasive blood pressure (IBP) and capnography (EtCO 2 and InCO 2 ).
The intended patient populations are: adults and pediatrics of at least 14 years of age and weighing more than 35 kg and infants can only be monitored with the oscillometric cuff.
Environment of use: All areas of a hospital and hospital type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist.
Note: Hospital use typically includes such areas as general care floors, operating rooms, special procedure areas, intensive and critical care area, within the hospital. Hospital type facilities include physician office based facilities, sleep labs, skilled nursing facilities, surgical centers, and sub acute care centers.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K063690 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063690: Colin Press Mate, Model BP S510.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063690
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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