510(k) · Cleared
ClearedTytan Blood Pressure Cuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tytan Medical Corp. · DXQ Blood Pressure Cuff
Cleared on Sep 21, 2006 as substantially equivalent to K051539 (Ya Horng Electronic Co., Ltd., 2005) after a 50-day review. Its family tree reaches back 2 generations to 2001. 24 later devices descend from it.
- Decided
- Sep 21, 2006
- Review
- 50 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010686 (2001). 24 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK010686 KTJ-20C Blood Pressure Cuff, Model KTJ-20CGolden Horse Medical Equipment (Wuxi) Co., Ltd. · 2001
- 1 generation backK051539 Tricot Blood Pressure CuffYa Horng Electronic Co., Ltd. · 2005
- This deviceK062238 Tytan Blood Pressure CuffTytan Medical Corp. · 2006
- Descendant · cites it directly · 23 of its ownK102825 Blood Pressure CuffAPK Technology Co., Ltd. · 2011
- Descendant · 2 generations on · 15 of its ownK113623 Patient MonitorEdan Instruments, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 14 of its ownK131971 IM60/IM70 Patient MonitorEdan Instruments, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 10 of its ownK120173 Patient MonitorEdan Instruments, Inc. · 2012
- Descendant · 3 generations on · 8 of its ownK160981 Patient MonitorEdan Instruments, Inc. · 2016 · Recalled
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K102825Blood Pressure CuffAPK Technology Co., Ltd. · 2011 · cites it directly23descendants
- K113623Patient MonitorEdan Instruments, Inc. · 2012 · 2 generations on15descendants
- K131971IM60/IM70 Patient MonitorEdan Instruments, Inc. · 2014 · 3 generations on14descendants
- K120173Patient MonitorEdan Instruments, Inc. · 2012 · 2 generations on10descendants
- K160981Patient MonitorEdan Instruments, Inc. · 2016 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K062238 | Tytan Blood Pressure Cuff | Tytan Medical Corp. | 2006 | — |
| +1 | K102825 | Blood Pressure Cuff | APK Technology Co., Ltd. | 2011 | — |
| +2 | K113623 | Patient Monitor | Edan Instruments, Inc. | 2012 | 2 |
| +3 | K131971 | IM60/IM70 Patient Monitor | Edan Instruments, Inc. | 2014 | 2 |
| +2 | K120173 | Patient Monitor | Edan Instruments, Inc. | 2012 | — |
| +3 | K160981 | Patient Monitor | Edan Instruments, Inc. | 2016 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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? (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 |
|---|---|---|---|
| * | K051539 | Tricot Blood Pressure CuffSummary page 3…narket notification, TYTAN Medical Corp. concludes that the TYTAN Blood Pressure Cuff is safe, effective and substantially equivalent to the TRICOT BLOOD PRESSURE CUFF ( K05 1539 ) predicate device as described herein and meets the relevant requirements of ANSI/AAMI SP9-1994. ~** DEPA… | 2005 |
What descends from it? (24)
See all 241 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102825 | Blood Pressure Cuff | 2011 | 23 |
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 5 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K102825 (APK Technology Co., Ltd., 2011) has gone furthest, with 23 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 | — |
What is it indicated for?
The TYTAN blood pressure cuff is used in conjunction with non-invasive blood pressure measurement systems by personnel properly trained. The device is non-sterile and is intended as a reusable multi-patient device for measuring one's blood pressure. It is available in newborn through large adult sizes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062238 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062238: Tytan Blood Pressure Cuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062238
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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