510(k) · Cleared
ClearedReizen Talking Blood Pressure Monitor, Model #SF860T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maxi-Aids, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Aug 31, 2004 after a 61-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Aug 31, 2004
- Review
- 61 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK041778 Reizen Talking Blood Pressure Monitor, Model #SF860TMaxi-Aids, Inc. · 2004
- Descendant · cites it directly · 4 of its ownK111652 Microlife Automatic Talking Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2011
- Descendant · 2 generations on · 3 of its ownK131346 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2013
- Descendant · 3 generations on · 2 of its ownK172880 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2018
- Descendant · 4 generations on · 1 of its ownK183469 Microlife Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2019
- Descendant · 5 generations on · 0 of its ownK190818 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2019
Most influential descendants
Showing 5 of 5 · See all- K111652Microlife Automatic Talking Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2011 · cites it directly4descendants
- K131346Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2013 · 2 generations on3descendants
- K172880Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2018 · 3 generations on2descendants
- K183469Microlife Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2019 · 4 generations on1descendant
- K190818Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2019 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041778 | Reizen Talking Blood Pressure Monitor, Model #SF860T | Maxi-Aids, Inc. | 2004 | — |
| +1 | K111652 | Microlife Automatic Talking Blood Pressure Monitor | Microlife Intellectual Property GmbH | 2011 | — |
| +2 | K131346 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | 2013 | — |
| +3 | K172880 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | 2018 | — |
| +4 | K183469 | Microlife Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | 2019 | — |
| +5 | K190818 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 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 DXN? 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 DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | A&D Medical LifeSource Talking Digital Blood Pressure Monitor, Model UA-767TI Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111652 | Microlife Automatic Talking Blood Pressure Monitor | 2011 | 4 |
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, K111652 (Microlife Intellectual Property GmbH, 2011) has gone furthest, with 4 descendants of its own.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, 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 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
The device measures systolic and diastolic blood pressures and pulse rate. It uses the oscillometric method. It is indicated for use by adults (those 18 years of age and older) at home or in an outpatient setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041778 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041778: Reizen Talking Blood Pressure Monitor, Model #SF860T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041778
Report an extraction error
Are you the manufacturer?
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