510(k) · Cleared
ClearedTL10 Tensymeter Blood Pressure Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tensys Medical, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Aug 15, 2002 as substantially equivalent to K900247 (Colin Medical Instruments Corp., 1990) after a 177-day review. Its family tree reaches back 1 generation to 1990. 3 later devices descend from it.
- Decided
- Aug 15, 2002
- Review
- 177 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K900247 (1990). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK900247 CBM-3000/CBM-2000/CBM-7000 Blood Pressure SystemColin Medical Instruments Corp. · 1990
- This deviceK020537 TL10 Tensymeter Blood Pressure Monitoring SystemTensys Medical, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK223873 Boppli Infant Blood Pressure MonitorPyrames, Inc. · 2023 · Recalled
- Descendant · cites it directly · 0 of its ownK201302 LiveOneLivemetric (Medical) S.A. · 2022
- Descendant · cites it directly · 0 of its ownK022783 TL100 Tensmeter Blood Pressure Monitoring SystemTensys Medical, Inc. · 2002
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900247 | CBM-3000/CBM-2000/CBM-7000 Blood Pressure System | Colin Medical Instruments Corp. | 1990 | — |
| 0 (this device) | K020537 | TL10 Tensymeter Blood Pressure Monitoring System | Tensys Medical, Inc. | 2002 | — |
| +1 | K223873 | Boppli Infant Blood Pressure Monitor | Pyrames, Inc. | 2023 | 1 |
| +1 | K201302 | LiveOne | Livemetric (Medical) S.A. | 2022 | — |
| +1 | K022783 | TL100 Tensmeter Blood Pressure Monitoring System | Tensys Medical, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K900247 | CBM-3000/CBM-2000/CBM-7000 Blood Pressure SystemSummary page 1…Tensys Medical, Inc. believes that the TLlO Tensymeter is substantially equivalent to the Colin Medical Instruments Corp.CBM-7000 Blood Pressure System (K900247) Confidential Page 76 of 80 Device Desc… | 1990 |
What descends from it? (3)
3 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.
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?
This device is intended for use by medically trained personnel in a clinical setting to
continually monitor and display diastolic, systolic, and mean blood pressures and
pulse rate. The device is intended for use on adult patients with a palpable pulse.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020537 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020537: TL10 Tensymeter Blood Pressure Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020537
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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