510(k) · Cleared
ClearedMicrolife Manual Blood Pressure Monitor (Manual Inflate) Model BP-2BIO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Weiss Electronics · DPW Flowmeter, Blood, Cardiovascular
Cleared on Apr 30, 1998 as substantially equivalent to K903133 (Omron Marshall Products, Inc., 1991) after a 470-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.
- Decided
- Apr 30, 1998
- Review
- 470 days
- Class
- Class II
- Product code
- DPW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K903133 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK903133 Omron Oscillometric Digital BP Monitor-Hem-405COmron Marshall Products, Inc. · 1991
- This deviceK970139 Microlife Manual Blood Pressure Monitor (Manual Inflate) Model BP-2BIOMicro Weiss Electronics · 1998
- Descendant · cites it directly · 0 of its ownK073397 Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H…Microlife Corp. · 2007
Most influential descendants
Showing 1 of 1 · See all- K073397Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H (BP A50)Microlife Corp. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903133 | Omron Oscillometric Digital BP Monitor-Hem-405C | Omron Marshall Products, Inc. | 1991 | — |
| 0 (this device) | K970139 | Microlife Manual Blood Pressure Monitor (Manual Inflate) Model BP-2BIO | Micro Weiss Electronics | 1998 | — |
| +1 | K073397 | Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H (BP A50) | Microlife Corp. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 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 DPW? 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 DPW device
- #1 K251114 FloPatch FP120score 13.7 · 5 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 |
|---|---|---|---|
| * | K903133 | Omron Oscillometric Digital BP Monitor-Hem-405CSummary page 1…ion: The MicroLife Manual Blood Pressure Monitor, Model BP-2BIO is substantially equivalent to the Omron Oscillometric Digital Blood Pressure Monitor, Model HEM-405C, K#903133. Device D ription: The BP-2BIO Digital Blood Pressure Monitor is designed to measure the systolic and diastolic blood pressure… | 1991 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073397 | Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H (BP A50) | 2007 | 0 |
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?
How does its category compare?
All DPW devicesDPW Flowmeter, Blood, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DPW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPW
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPW
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DPW
6in 2025
MAUDE reports naming product code DPW, 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 | — | 4 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 2 | — | 1 | 0 |
| 2011 | 4 | 89 | 0 | 1 |
| 2012 | 1 | — | 1 | 0 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 3 | 275 | 0 | 12 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 3 | 169 | 0 | 3 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 3 | 136 | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 3 | 119 | 1 | 6 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The BP-2BIO Digital Blood Pressure Monitor is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970139: Microlife Manual Blood Pressure Monitor (Manual Inflate) Model BP-2BIO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970139
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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