510(k) · Cleared
ClearedTenso TS-101S and TS-101D Disposable Blood Pressure Cuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd. · DXQ Blood Pressure Cuff
Cleared on Apr 14, 2016 as substantially equivalent to K151290 (Xuzhou Maicuff Technology Co., Ltd., 2015) and 1 other predicate after a 156-day review. Its family tree reaches back 4 generations to 1979.
- Decided
- Apr 14, 2016
- Review
- 156 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K790810 (1979). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK790810 Disposa-CufCrest Medical Equipment · 1979
- 3 generations backK974080 Critikon Soft Blood Pressure CuffJohnson & Johnson Medical, Inc. · 1998 · Recalled
- 2 generations backK120364 Unimed Disposable Blood Pressure CuffUnimed Medical Supplies, Inc. · 2012
- 1 generation backK151290 Disposable Blood Pressure Cuff, Reusable Blood Pressure CuffXuzhou Maicuff Technology Co., Ltd. · 2015
- This deviceK153251 Tenso TS-101S and TS-101D Disposable Blood Pressure CuffNingbo Free Trade Zone Tenso Medical Instruments Co., Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K790810 | Disposa-Cuf | Crest Medical Equipment | 1979 | — |
| −3 | K974080 | Critikon Soft Blood Pressure Cuff | Johnson & Johnson Medical, Inc. | 1998 | 1 |
| −2 | K120364 | Unimed Disposable Blood Pressure Cuff | Unimed Medical Supplies, Inc. | 2012 | — |
| −1 | K151290 | Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff | Xuzhou Maicuff Technology Co., Ltd. | 2015 | — |
| 0 (this device) | K153251 | Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff | Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 2002 | 1 | 0 |
| 2011 | 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 DXQ? 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 DXQ device
- #1 K254287 Medline Reusable Blood Pressure Cuffscore 13.4 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K151290 | Disposable Blood Pressure Cuff, Reusable Blood Pressure CuffSummary page 4…II Classification Regulation: 21 CFR 870.1120 Panel: Cardiovascular Product Code: DXQ 5.5 Predicate Device Information: (1) K151290, “Disposable/Reusable Blood Pressure Cuff”, manufactured by “Xuzhou Maicuff Technology Co., Ltd.” (for arm cuffs)… | 2015 |
| * | K120364 | Unimed Disposable Blood Pressure CuffSummary page 4…ice Information: (1) K151290, “Disposable/Reusable Blood Pressure Cuff”, manufactured by “Xuzhou Maicuff Technology Co., Ltd.” (for arm cuffs) (2) K120364, “Unined Disposable Blood Pressure Cuff”, manufactured by “Unined Medical supplies Inc.” (for thigh cuffs) 5.6 De… | 2012 |
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 37 years and passes through 5 companies; a new generation was cleared every 14.0 years on median.
- 2 of the 10 ancestors have a recall of any class.
- 4 other devices also cite its predicate K151290.
How does its category compare?
All DXQ devicesDXQ Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DXQ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXQ
174in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXQ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXQ
20in 2025
MAUDE reports naming product code DXQ, 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 | 2 | — | 0 | 3 |
| 2008 | 7 | 118 | 0 | 4 |
| 2009 | 5 | 57 | 0 | 2 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 5 | 121 | 1 | 5 |
| 2012 | 4 | 102 | 0 | 7 |
| 2013 | 2 | — | 0 | 9 |
| 2014 | 4 | 105 | 0 | 9 |
| 2015 | 10 | 59 | 0 | 23 |
| 2016 | 4 | 217 | 0 | 50 |
| 2017 | 2 | — | 0 | 67 |
| 2018 | 5 | 225 | 0 | 44 |
| 2019 | 3 | 44 | 0 | 41 |
| 2020 | 3 | 207 | 0 | 5 |
| 2021 | 4 | 105 | 0 | 12 |
| 2022 | 4 | 105 | 0 | 3 |
| 2023 | 5 | 79 | 0 | 20 |
| 2024 | 2 | — | 0 | 15 |
| 2025 | 3 | 174 | 1 | 20 |
| 2026 | 4 | 102 | 0 | — |
What is it indicated for?
The Tenso TS-101S and TS-101D disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in infant, pediatric and adult sizes. They are used in hospital settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153251 · printed Nov 3, 2026
Cite this page
510(k) Report. “K153251: Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K153251
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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