510(k) · Cleared
ClearedBiospace
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biospace Corporation Limited · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Sep 4, 2013 as substantially equivalent to K010828 (A&D Engineering, Inc., 2001) after a 141-day review. Its family tree reaches back 1 generation to 2001. 4 later devices descend from it.
- Decided
- Sep 4, 2013
- Review
- 141 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010828 (2001). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK010828 Digital Blood Pressure Monitors, Models TM-2655, TM-2655P, & TM-2655VPA&D Engineering, Inc. · 2001
- This deviceK131064 BiospaceBiospace Corporation Limited · 2013
- Descendant · cites it directly · 2 of its ownK200442 InBodyInbody Co., Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK221764 InBody Blood pressure monitor, Model BPBIO480KVInbody Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK250091 KOROT Blood Pressure Monitor (KOROT P3 Accurate)Korot Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK231174 BPBIO750Inbody Co., Ltd. · 2023
Most influential descendants
Showing 4 of 4 · See all- K200442InBodyInbody Co., Ltd. · 2020 · cites it directly2descendants
- K221764InBody Blood pressure monitor, Model BPBIO480KVInbody Co., Ltd. · 2022 · 2 generations on1descendant
- K250091KOROT Blood Pressure Monitor (KOROT P3 Accurate)Korot Co., Ltd. · 2025 · 3 generations on0descendants
- K231174BPBIO750Inbody Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010828 | Digital Blood Pressure Monitors, Models TM-2655, TM-2655P, & TM-2655VP | A&D Engineering, Inc. | 2001 | — |
| 0 (this device) | K131064 | Biospace | Biospace Corporation Limited | 2013 | — |
| +1 | K200442 | InBody | Inbody Co., Ltd. | 2020 | — |
| +2 | K221764 | InBody Blood pressure monitor, Model BPBIO480KV | Inbody Co., Ltd. | 2022 | — |
| +3 | K250091 | KOROT Blood Pressure Monitor (KOROT P3 Accurate) | Korot Co., Ltd. | 2025 | — |
| +1 | K231174 | BPBIO750 | Inbody Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K010828 | Digital Blood Pressure Monitors, Models TM-2655, TM-2655P, & TM-2655VPSummary page 1…: 11, Product Code: DXN 2. Equivalent legally marketed devices: (Predicate device Information) A&D Engineering Inc. Digital Blood pressure monitors Model TM2655P (K010828) 3. Indications for Use (intended use) The Biospace blood pressure monitor is designed to measure blood pressure (diastolic a… | 2001 |
What descends from it? (4)
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?
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. 2013, 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 Biospace blood pressure monitor is designed to measure blood pressure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 17cm - 42cm. (BPBIO32On is the same device as the BPB10320 and has same specifications except it has no printer module.)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131064 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131064: Biospace.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131064
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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