510(k) · Cleared
ClearedOstar Usb Blood Pressure Monitor with Spectrum / P200 for Upper Arm, and M100 for Wrist Type
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ostar Meditech Corp. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Oct 20, 2011 as substantially equivalent to K103046 (Hosman International Co., Ltd., 2011) after a 73-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Oct 20, 2011
- Review
- 73 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K001182 (2000). No later device cites it as a predicate yet.
- Root · 6 generations backK001182 Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1Microlife Corp. · 2000
- 5 generations backK012796 Amluck Automatic Digital Wrist, Blood Pressure Monitor AK-3000/AK-4000Amluck, Inc. · 2002
- 4 generations backK051862 PC Compatible Blood Pressure Monitor, Model AK-4000TU, BP-410U…Ya Horng Electronic Co., Ltd. · 2005
- 3 generations backK072860 YA Horng Digital Upper Arm Blood Pressure Monitor, BP-100J, BP-110J…Ya Horng Electronic Co., Ltd. · 2008
- 2 generations backK090058 YA Horng Digital Upper Arm Blood Pressure Monitor, BP-700, BP-700T…Ya Horng Electronic Co., Ltd. · 2009
- 1 generation backK103046 Hosman Usb Blood Pressure Monitor; Wrist Type and Upper Arm TypeHosman International Co., Ltd. · 2011
- This deviceK112269 Ostar Usb Blood Pressure Monitor with Spectrum / P200 for Upper Arm…Ostar Meditech Corp. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001182 | Microlife Wrist Watch Blood Pressure Monitor, Model BP-3BU1 | Microlife Corp. | 2000 | — |
| −5 | K012796 | Amluck Automatic Digital Wrist, Blood Pressure Monitor AK-3000/AK-4000 | Amluck, Inc. | 2002 | — |
| −4 | K051862 | PC Compatible Blood Pressure Monitor, Model AK-4000TU, BP-410U, BP-410R… | Ya Horng Electronic Co., Ltd. | 2005 | — |
| −3 | K072860 | YA Horng Digital Upper Arm Blood Pressure Monitor, BP-100J, BP-110J; Digital… | Ya Horng Electronic Co., Ltd. | 2008 | — |
| −2 | K090058 | YA Horng Digital Upper Arm Blood Pressure Monitor, BP-700, BP-700T, BP700U… | Ya Horng Electronic Co., Ltd. | 2009 | — |
| −1 | K103046 | Hosman Usb Blood Pressure Monitor; Wrist Type and Upper Arm Type | Hosman International Co., Ltd. | 2011 | — |
| 0 (this device) | K112269 | Ostar Usb Blood Pressure Monitor with Spectrum / P200 for Upper Arm, and M100… | Ostar Meditech Corp. | 2011 | — |
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 |
|---|---|---|---|
| * | K103046 | Hosman Usb Blood Pressure Monitor; Wrist Type and Upper Arm TypeSummary page 1…Neurology Product Code :DXN Device Class : 1 3. Information of the 510(k) Cleared Device (Predicate Device): - HOSMAN model HM500 (K1 03046) for P200 upper arm model - HOSMAN model HM100(K103046) for M100 wrist model 4. Device Description: Basically the measur… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 companies; a new generation was cleared every 1.7 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K103046.
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?
OSTAR USB Blood Pressure Monitor Upper Arm Type: P200 and Wrist Type: M100, are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressure 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 rm.
The cuff circumference is limited to be 5.5'-7.8'(14 cm -20 cm) for wrist type, and 9'-i 3'(24cm -32cm) for Uipper Arm Type.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112269 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112269: Ostar Usb Blood Pressure Monitor with Spectrum / P200 for Upper Arm, and M100 for Wrist Type.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112269
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