510(k) · Cleared
ClearedBlood Pressure Cuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
APK Technology Co., Ltd. · DXQ Blood Pressure Cuff
Cleared on Mar 2, 2011 as substantially equivalent to K062238 (Tytan Medical Corp., 2006) after a 154-day review. Its family tree reaches back 3 generations to 2001. 23 later devices descend from it.
- Decided
- Mar 2, 2011
- Review
- 154 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K010686 (2001). 23 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK010686 KTJ-20C Blood Pressure Cuff, Model KTJ-20CGolden Horse Medical Equipment (Wuxi) Co., Ltd. · 2001
- 2 generations backK051539 Tricot Blood Pressure CuffYa Horng Electronic Co., Ltd. · 2005
- 1 generation backK062238 Tytan Blood Pressure CuffTytan Medical Corp. · 2006
- This deviceK102825 Blood Pressure CuffAPK Technology Co., Ltd. · 2011
- Descendant · cites it directly · 15 of its ownK113623 Patient MonitorEdan Instruments, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 14 of its ownK131971 IM60/IM70 Patient MonitorEdan Instruments, Inc. · 2014 · Recalled
- Descendant · cites it directly · 10 of its ownK120173 Patient MonitorEdan Instruments, Inc. · 2012
- Descendant · 2 generations on · 8 of its ownK160981 Patient MonitorEdan Instruments, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 6 of its ownK192514 Patient MonitorEdan Instruments, Inc. · 2020 · Recalled
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K113623Patient MonitorEdan Instruments, Inc. · 2012 · cites it directly15descendants
- K131971IM60/IM70 Patient MonitorEdan Instruments, Inc. · 2014 · 2 generations on14descendants
- K120173Patient MonitorEdan Instruments, Inc. · 2012 · cites it directly10descendants
- K160981Patient MonitorEdan Instruments, Inc. · 2016 · 2 generations on8descendants
- K192514Patient MonitorEdan Instruments, Inc. · 2020 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010686 | KTJ-20C Blood Pressure Cuff, Model KTJ-20C | Golden Horse Medical Equipment (Wuxi) Co., Ltd. | 2001 | — |
| −2 | K051539 | Tricot Blood Pressure Cuff | Ya Horng Electronic Co., Ltd. | 2005 | — |
| −1 | K062238 | Tytan Blood Pressure Cuff | Tytan Medical Corp. | 2006 | — |
| 0 (this device) | K102825 | Blood Pressure Cuff | APK Technology Co., Ltd. | 2011 | — |
| +1 | K113623 | Patient Monitor | Edan Instruments, Inc. | 2012 | 2 |
| +2 | K131971 | IM60/IM70 Patient Monitor | Edan Instruments, Inc. | 2014 | 2 |
| +1 | K120173 | Patient Monitor | Edan Instruments, Inc. | 2012 | — |
| +2 | K160981 | Patient Monitor | Edan Instruments, Inc. | 2016 | 1 |
| +3 | K192514 | Patient Monitor | Edan Instruments, Inc. | 2020 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K080850 | FDA’s K080850 is Darco Headless Compression Screw Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2008 |
| * | K062238 | Tytan Blood Pressure CuffSummary page 3…Equivalent (SE) to the predicate devices, Disposable Blood Pressure Cuff, K08085 and Thtan Blood Pressure Cuff, K062238. 11-3… | 2006 |
What descends from it? (23)
See all 233 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 10 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K113623 (Edan Instruments, Inc., 2012) has gone furthest, with 15 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. 2011, 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, include reusable and disposable, are intended to be wrapped on the upper arm and used with a non-invasive blood pressure monitor system to determine blood parameters on neonate, pediatric and adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102825 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102825: 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/K102825
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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