510(k) · Cleared
ClearedHosman Usb Blood Pressure Monitor; Wrist Type and Upper Arm Type
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hosman International Co., Ltd. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jan 10, 2011 as substantially equivalent to K090058 (Ya Horng Electronic Co., Ltd., 2009) after an 88-day review. Its family tree reaches back 5 generations to 2000. 2 later devices descend from it.
- Decided
- Jan 10, 2011
- Review
- 88 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K001182 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK001182 Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1Microlife Corp. · 2000
- 4 generations backK012796 Amluck Automatic Digital Wrist, Blood Pressure Monitor AK-3000/AK-4000Amluck, Inc. · 2002
- 3 generations backK051862 PC Compatible Blood Pressure Monitor, Model AK-4000TU, BP-410U…Ya Horng Electronic Co., Ltd. · 2005
- 2 generations backK072860 YA Horng Digital Upper Arm Blood Pressure Monitor, BP-100J, BP-110J…Ya Horng Electronic Co., Ltd. · 2008
- 1 generation backK090058 YA Horng Digital Upper Arm Blood Pressure Monitor, BP-700, BP-700T…Ya Horng Electronic Co., Ltd. · 2009
- This deviceK103046 Hosman Usb Blood Pressure Monitor; Wrist Type and Upper Arm TypeHosman International Co., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK122443 Ufit Ten-10Biosign Technologies, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK112269 Ostar Usb Blood Pressure Monitor with Spectrum / P200 for Upper Arm…Ostar Meditech Corp. · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001182 | Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1 | Microlife Corp. | 2000 | — |
| −4 | K012796 | Amluck Automatic Digital Wrist, Blood Pressure Monitor AK-3000/AK-4000 | Amluck, Inc. | 2002 | — |
| −3 | K051862 | PC Compatible Blood Pressure Monitor, Model AK-4000TU, BP-410U, BP-410R… | Ya Horng Electronic Co., Ltd. | 2005 | — |
| −2 | K072860 | YA Horng Digital Upper Arm Blood Pressure Monitor, BP-100J, BP-110J; Digital… | Ya Horng Electronic Co., Ltd. | 2008 | — |
| −1 | K090058 | YA Horng Digital Upper Arm Blood Pressure Monitor, BP-700, BP-700T, BP700U… | Ya Horng Electronic Co., Ltd. | 2009 | — |
| 0 (this device) | K103046 | Hosman Usb Blood Pressure Monitor; Wrist Type and Upper Arm Type | Hosman International Co., Ltd. | 2011 | — |
| +1 | K122443 | Ufit Ten-10 | Biosign Technologies, Inc. | 2012 | — |
| +1 | K112269 | Ostar Usb Blood Pressure Monitor with Spectrum / P200 for Upper Arm, and M100… | Ostar Meditech Corp. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 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 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 |
|---|---|---|---|
| * | K090058 | YA Horng Digital Upper Arm Blood Pressure Monitor, BP-700, BP-700T, BP700U, BP-700B…Summary page 1…ressure (Predicate) Device: Monitor BP-700, BP-700T, BP-700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB 510(k) No: K090058 El -OFiI3… | 2009 |
What descends from it? (2)
2 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 11 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K122443 (Biosign Technologies, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K090058.
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. 2011, this device’s year, is highlighted.
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 H6SMAN USB Blood Pressure Monitor, Upper Arm Type: HM-500 and Wrist Type: HM-l00, are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist or upper arm.
The cuff circumference is limited to be 5.3'-7.7' (13.5 cnml9.5 cm) for wrist type; and 8.7'-14.6' (22 cm-37 cm) for Upper Arm type.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103046 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103046: Hosman Usb Blood Pressure Monitor; Wrist Type and Upper Arm Type.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103046
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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