510(k) · Cleared
ClearedOmron Model HBP-2070 Vital Signs Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omron Healthcare, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Oct 22, 2008 as substantially equivalent to K973637 (Colin Medical Instruments Corp., 1998) and 2 other predicates after a 28-day review. Its family tree reaches back 4 generations to 1987. 27 later devices descend from it.
- Decided
- Oct 22, 2008
- Review
- 28 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K872291 (1987). 8 ancestors in all. 27 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK872291 Escort Portable Patient MonitorMedical Data Electronics · 1987
- 3 generations backK973637 Press-Mate AdvantageColin Medical Instruments Corp. · 1998
- 2 generations backK022537 Press-Mate PM-2100 Vital Sign MonitorColin Medical Instruments Corp. · 2002
- 1 generation backK071645 Model HBP T-105 Series, Model T-105 and T-105SOmron Healthcare, Inc. · 2007
- This deviceK082812 Omron Model HBP-2070 Vital Signs MonitorOmron Healthcare, Inc. · 2008
- Descendant · cites it directly · 24 of its ownK112478 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 20 of its ownK122036 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 19 of its ownK130709 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2013
- Descendant · 3 generations on · 18 of its ownK133586 Visi Mobile Monitioring SystemSotera Wireless, Inc. · 2013
- Descendant · 3 generations on · 17 of its ownK143751 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2015
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K112478Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · cites it directly24descendants
- K122036Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · 2 generations on20descendants
- K130709Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2013 · 2 generations on19descendants
- K133586Visi Mobile Monitioring SystemSotera Wireless, Inc. · 2013 · 3 generations on18descendants
- K143751Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2015 · 3 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K872291 | Escort Portable Patient Monitor | Medical Data Electronics | 1987 | — |
| −3 | K973637 | Press-Mate Advantage | Colin Medical Instruments Corp. | 1998 | — |
| −2 | K022537 | Press-Mate PM-2100 Vital Sign Monitor | Colin Medical Instruments Corp. | 2002 | — |
| −1 | K071645 | Model HBP T-105 Series, Model T-105 and T-105S | Omron Healthcare, Inc. | 2007 | — |
| 0 (this device) | K082812 | Omron Model HBP-2070 Vital Signs Monitor | Omron Healthcare, Inc. | 2008 | — |
| +1 | K112478 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2012 | 2 |
| +2 | K122036 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2012 | 2 |
| +2 | K130709 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2013 | — |
| +3 | K133586 | Visi Mobile Monitioring System | Sotera Wireless, Inc. | 2013 | — |
| +3 | K143751 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 MWI? 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 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 |
|---|---|---|---|
| * | K973637 | Press-Mate AdvantageSummary page 1…- System, Measurement, Blood-pressure, Non-invasive Device: Model - HBP-2070 Predicate Devices: Omron - Press-Mate Advantage - K973637 Device Description: The proposed vital signs monitor is a modification of a previously cleared Colin Press Mate Advantage (K9736… | 1998 |
| * | K063690 | Colin Press Mate, Model BP S510Summary page 4…e Nellcor MP-203 Nellcor NELL-3 Predicate Oreon BP-S5 10 (K063690) Measurement method 2 wave length pulse wave type same as predicate device SpO2 display range… | 2007 |
| * | K071645 | Model HBP T-105 Series, Model T-105 and T-105SSummary page 3…Pediatric / Neonatal) 30 -100 mmHg which has been used in our predicate DIA - Adult) 40- 200 mmHg HBP-TI05 (K071645) Pediatric / Neonatal) 20 -90 mmHg Pressure display range 10- 300 mmHg… | 2007 |
What descends from it? (27)
See all 273 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 21 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K112478 (Sotera Wireless, Inc., 2012) has gone furthest, with 24 descendants of its own.
- 4 other devices also cite its predicate K973637.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
The HBP-2070 is intended to be used to monitor electrocardiography (ECG),heart rate (HR), noninvasive blood pressure (systolic, diastolic and mean arterial pressure) (NIBP), functional arterial oxygen saturation (SpO 2), pulse rate (PR), respiration (RR) temperature (Temp) for adult, pediatric, and neonatal patients in 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082812: Omron Model HBP-2070 Vital Signs Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082812
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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