510(k) · Cleared
ClearedKTJ-20C Blood Pressure Cuff, Model KTJ-20C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Golden Horse Medical Equipment (Wuxi) Co., Ltd. · DXQ Blood Pressure Cuff
Cleared on Mar 21, 2001 after a 13-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 26 later devices descend from it.
- Decided
- Mar 21, 2001
- Review
- 13 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 0
26 later devices descend from it, 1 citing it directly.
- This deviceK010686 KTJ-20C Blood Pressure Cuff, Model KTJ-20CGolden Horse Medical Equipment (Wuxi) Co., Ltd. · 2001
- Descendant · cites it directly · 25 of its ownK051539 Tricot Blood Pressure CuffYa Horng Electronic Co., Ltd. · 2005
- Descendant · 2 generations on · 24 of its ownK062238 Tytan Blood Pressure CuffTytan Medical Corp. · 2006
- Descendant · 3 generations on · 23 of its ownK102825 Blood Pressure CuffAPK Technology Co., Ltd. · 2011
- Descendant · 4 generations on · 15 of its ownK113623 Patient MonitorEdan Instruments, Inc. · 2012 · Recalled
- Descendant · 5 generations on · 14 of its ownK131971 IM60/IM70 Patient MonitorEdan Instruments, Inc. · 2014 · Recalled
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K051539Tricot Blood Pressure CuffYa Horng Electronic Co., Ltd. · 2005 · cites it directly25descendants
- K062238Tytan Blood Pressure CuffTytan Medical Corp. · 2006 · 2 generations on24descendants
- K102825Blood Pressure CuffAPK Technology Co., Ltd. · 2011 · 3 generations on23descendants
- K113623Patient MonitorEdan Instruments, Inc. · 2012 · 4 generations on15descendants
- K131971IM60/IM70 Patient MonitorEdan Instruments, Inc. · 2014 · 5 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010686 | KTJ-20C Blood Pressure Cuff, Model KTJ-20C | Golden Horse Medical Equipment (Wuxi) Co., Ltd. | 2001 | — |
| +1 | K051539 | Tricot Blood Pressure Cuff | Ya Horng Electronic Co., Ltd. | 2005 | — |
| +2 | K062238 | Tytan Blood Pressure Cuff | Tytan Medical Corp. | 2006 | — |
| +3 | K102825 | Blood Pressure Cuff | APK Technology Co., Ltd. | 2011 | — |
| +4 | K113623 | Patient Monitor | Edan Instruments, Inc. | 2012 | 2 |
| +5 | K131971 | IM60/IM70 Patient Monitor | Edan Instruments, Inc. | 2014 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (26)
See all 261 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051539 | Tricot Blood Pressure Cuff | 2005 | 25 |
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?
- Of its descendants, K051539 (Ya Horng Electronic Co., Ltd., 2005) has gone furthest, with 25 descendants of its own.
How does its category compare?
All DXQ devicesDXQ Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K010686 · printed Nov 3, 2026
Cite this page
510(k) Report. “K010686: KTJ-20C Blood Pressure Cuff, Model KTJ-20C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K010686
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026