510(k) · Cleared
ClearedAmbulatory Blood Pressure Monitor, MDL# 5100-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welch Allyn, Inc. · DSK Computer, Blood-Pressure
Cleared on May 21, 1993 after a 182-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- May 21, 1993
- Review
- 182 days
- Class
- Class II
- Product code
- DSK
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK925899 Ambulatory Blood Pressure Monitor, MDL# 5100-01Welch Allyn, Inc. · 1993
- Descendant · cites it directly · 6 of its ownK021756 Welch Allyn Abpm 6100Welch Allyn, Inc. · 2002
- Descendant · 2 generations on · 5 of its ownK082881 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model…Microlife Intellectual Property GmbH · 2008
- Descendant · 3 generations on · 3 of its ownK093013 Blood Pressure Monitor, Model MD200ABeijing Choice Electronic Technololgy Co., Ltd. · 2010
- Descendant · 3 generations on · 0 of its ownK202729 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2021
- Descendant · 4 generations on · 0 of its ownK130056 Patient MonitorLd Technology, LLC · 2013
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K021756Welch Allyn Abpm 6100Welch Allyn, Inc. · 2002 · cites it directly6descendants
- K082881Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watchbp O3Microlife Intellectual Property GmbH · 2008 · 2 generations on5descendants
- K093013Blood Pressure Monitor, Model MD200ABeijing Choice Electronic Technololgy Co., Ltd. · 2010 · 3 generations on3descendants
- K202729Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2021 · 3 generations on0descendants
- K130056Patient MonitorLd Technology, LLC · 2013 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925899 | Ambulatory Blood Pressure Monitor, MDL# 5100-01 | Welch Allyn, Inc. | 1993 | — |
| +1 | K021756 | Welch Allyn Abpm 6100 | Welch Allyn, Inc. | 2002 | — |
| +2 | K082881 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watchbp O3 | Microlife Intellectual Property GmbH | 2008 | — |
| +3 | K093013 | Blood Pressure Monitor, Model MD200A | Beijing Choice Electronic Technololgy Co., Ltd. | 2010 | — |
| +3 | K202729 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | 2021 | — |
| +4 | K130056 | Patient Monitor | Ld Technology, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2021 | 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 DSK? 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 DSK device
- #1 K231586 Endophys Blood Pressure Monitor model BPM-30score 8.7 · 9 generations · no Class I recall
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? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021756 | Welch Allyn Abpm 6100 | 2002 | 6 |
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, K021756 (Welch Allyn, Inc., 2002) has gone furthest, with 6 descendants of its own.
How does its category compare?
All DSK devicesDSK Computer, Blood-Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSK
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DSK
Too few DSK 510(k)s in any year since 2007 to give a median.
Recalls per year · DSK
No recall names DSK since 2007.
Adverse event reports per year · DSK
26in 2025
MAUDE reports naming product code DSK, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 69 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 1 | — | 0 | 13 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 93 |
| 2019 | 0 | — | 0 | 148 |
| 2020 | 0 | — | 0 | 29 |
| 2021 | 0 | — | 0 | 31 |
| 2022 | 0 | — | 0 | 29 |
| 2023 | 1 | — | 0 | 14 |
| 2024 | 0 | — | 0 | 12 |
| 2025 | 0 | — | 0 | 26 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K925899 · printed Nov 4, 2026
Cite this page
510(k) Report. “K925899: Ambulatory Blood Pressure Monitor, MDL# 5100-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K925899
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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