510(k) · Cleared
ClearedAndon Blood Pressure Cuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Andon Health Co, Ltd. · DXQ Blood Pressure Cuff
Cleared on Mar 4, 2014 as substantially equivalent to K102825 (APK Technology Co., Ltd., 2011) after a 155-day review. Its family tree reaches back 4 generations to 2001. 4 later devices descend from it.
- Decided
- Mar 4, 2014
- Review
- 155 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010686 (2001). 4 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK010686 KTJ-20C Blood Pressure Cuff, Model KTJ-20CGolden Horse Medical Equipment (Wuxi) Co., Ltd. · 2001
- 3 generations backK051539 Tricot Blood Pressure CuffYa Horng Electronic Co., Ltd. · 2005
- 2 generations backK062238 Tytan Blood Pressure CuffTytan Medical Corp. · 2006
- 1 generation backK102825 Blood Pressure CuffAPK Technology Co., Ltd. · 2011
- This deviceK133117 Andon Blood Pressure CuffAndon Health Co, Ltd. · 2014
- Descendant · cites it directly · 2 of its ownK171889 Reusable Blood Pressure CuffSuzhou Minhua Medical Apparatus Supplies Co., Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK233276 Reusable Blood Pressure CuffSuzhou Minhua Medical Apparatus Supplies Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK254287 Medline Reusable Blood Pressure CuffMedline Industries, LP · 2026
- Descendant · cites it directly · 0 of its ownK151810 Bpump Blood Pressure CuffShenzhen Pump Medical System Co., Ltd. · 2015
Most influential descendants
Showing 4 of 4 · See all- K171889Reusable Blood Pressure CuffSuzhou Minhua Medical Apparatus Supplies Co., Ltd. · 2017 · cites it directly2descendants
- K233276Reusable Blood Pressure CuffSuzhou Minhua Medical Apparatus Supplies Co., Ltd. · 2023 · cites it directly1descendant
- K254287Medline Reusable Blood Pressure CuffMedline Industries, LP · 2026 · 2 generations on0descendants
- K151810Bpump Blood Pressure CuffShenzhen Pump Medical System Co., Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010686 | KTJ-20C Blood Pressure Cuff, Model KTJ-20C | Golden Horse Medical Equipment (Wuxi) Co., Ltd. | 2001 | — |
| −3 | K051539 | Tricot Blood Pressure Cuff | Ya Horng Electronic Co., Ltd. | 2005 | — |
| −2 | K062238 | Tytan Blood Pressure Cuff | Tytan Medical Corp. | 2006 | — |
| −1 | K102825 | Blood Pressure Cuff | APK Technology Co., Ltd. | 2011 | — |
| 0 (this device) | K133117 | Andon Blood Pressure Cuff | Andon Health Co, Ltd. | 2014 | — |
| +1 | K171889 | Reusable Blood Pressure Cuff | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 2017 | — |
| +1 | K233276 | Reusable Blood Pressure Cuff | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 2023 | — |
| +2 | K254287 | Medline Reusable Blood Pressure Cuff | Medline Industries, LP | 2026 | — |
| +1 | K151810 | Bpump Blood Pressure Cuff | Shenzhen Pump Medical System Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 13.3 · 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? (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 |
|---|---|---|---|
| * | K102825 | Blood Pressure CuffSummary page 1…cate device information 1 Manufacturer: APK Technology Co, Ltd Device: Blood Pressure Cuff 510(k) number: K102825 K133117 page2of 3 Andon Blood Pressur Cuff FDA 5 10(k) Files 5… | 2011 |
What descends from it? (4)
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?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 4.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K171889 (Suzhou Minhua Medical Apparatus Supplies Co., Ltd., 2017) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K102825.
How does its category compare?
All DXQ devicesDXQ Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Blood Pressure Cuffs are intended to be wrapped on the upper arm and used with a non-invasive blood pressure monitor system to complete the measurement of blood parameters on adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133117: Andon Blood Pressure Cuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133117
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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