510(k) · Cleared
ClearedBP-8800 Blood Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Colin Medical Instruments Corp. · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cleared on Jun 22, 1989 after a 121-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 51 later devices descend from it.
- Decided
- Jun 22, 1989
- Review
- 121 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 0
51 later devices descend from it, 2 citing it directly.
- This deviceK890876 BP-8800 Blood Pressure MonitorColin Medical Instruments Corp. · 1989
- Descendant · cites it directly · 50 of its ownK022537 Press-Mate PM-2100 Vital Sign MonitorColin Medical Instruments Corp. · 2002
- Descendant · 2 generations on · 28 of its ownK071645 Model HBP T-105 Series, Model T-105 and T-105SOmron Healthcare, Inc. · 2007
- Descendant · 3 generations on · 27 of its ownK082812 Omron Model HBP-2070 Vital Signs MonitorOmron Healthcare, Inc. · 2008
- Descendant · 4 generations on · 24 of its ownK112478 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · Recalled
- Descendant · 5 generations on · 20 of its ownK122036 Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · Recalled
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 51 · See all- K022537Press-Mate PM-2100 Vital Sign MonitorColin Medical Instruments Corp. · 2002 · cites it directly50descendants
- K071645Model HBP T-105 Series, Model T-105 and T-105SOmron Healthcare, Inc. · 2007 · 2 generations on28descendants
- K082812Omron Model HBP-2070 Vital Signs MonitorOmron Healthcare, Inc. · 2008 · 3 generations on27descendants
- K112478Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · 4 generations on24descendants
- K122036Visi Mobile Monitoring SystemSotera Wireless, Inc. · 2012 · 5 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K890876 | BP-8800 Blood Pressure Monitor | Colin Medical Instruments Corp. | 1989 | — |
| +1 | K022537 | Press-Mate PM-2100 Vital Sign Monitor | Colin Medical Instruments Corp. | 2002 | — |
| +2 | K071645 | Model HBP T-105 Series, Model T-105 and T-105S | Omron Healthcare, Inc. | 2007 | — |
| +3 | K082812 | Omron Model HBP-2070 Vital Signs Monitor | Omron Healthcare, Inc. | 2008 | — |
| +4 | K112478 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2012 | 2 |
| +5 | K122036 | Visi Mobile Monitoring System | Sotera Wireless, Inc. | 2012 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 6 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRT? 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 DRT device
- #1 K252676 The Circadia C300 System (C300)score 15.3 · 6 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (51)
See all 512 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, K022537 (Colin Medical Instruments Corp., 2002) has gone furthest, with 50 descendants of its own.
How does its category compare?
All DRT devicesDRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRT
228in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRT
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRT
40in 2025
MAUDE reports naming product code DRT, 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 | 1 | — | 0 | 113 |
| 2008 | 1 | — | 0 | 99 |
| 2009 | 6 | 70 | 0 | 118 |
| 2010 | 3 | 44 | 0 | 63 |
| 2011 | 3 | 149 | 1 | 36 |
| 2012 | 1 | — | 0 | 47 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 48 |
| 2016 | 1 | — | 0 | 55 |
| 2017 | 1 | — | 0 | 159 |
| 2018 | 1 | — | 0 | 224 |
| 2019 | 1 | — | 0 | 447 |
| 2020 | 0 | — | 0 | 50 |
| 2021 | 2 | — | 1 | 85 |
| 2022 | 1 | — | 0 | 35 |
| 2023 | 1 | — | 0 | 47 |
| 2024 | 3 | 228 | 1 | 29 |
| 2025 | 1 | — | 0 | 40 |
| 2026 | 5 | 120 | 0 | — |
https://510kreport.com/device/K890876 · printed Nov 3, 2026
Cite this page
510(k) Report. “K890876: BP-8800 Blood Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K890876
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026