510(k) · Cleared
ClearedSmartdop XT6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Koven Technology, Inc. · JOP Transducer, Ultrasonic
Cleared on May 25, 2016 as substantially equivalent to K131623 (Koven Technology, Inc., 2014) after a 147-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- May 25, 2016
- Review
- 147 days
- Class
- Class II
- Product code
- JOP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K904392 (1991). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904392 | Multilab 2000 | Unetixs, Inc. | 1991 | 4 |
| −2 | K111416 | Falcon | Viasonix, Ltd. | 2011 | — |
| −1 | K131623 | Smartdop XT | Koven Technology, Inc. | 2014 | — |
| 0 (this device) | K153762 | Smartdop XT6 | Koven Technology, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 JOP? 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 JOP device
- #1 K242662 Falcon/Xpress (Falcon/Xpress)score 8.8 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K131623 | Smartdop XTSummary page 7…asive evaluation of peripheral vascular pathology now in market. The predicate device is the Smartdop XT manufactured by Hadeco Inc., Kawasaki, Japan, with S.E number of K131623. Device description: The Smartdop XT6 with Smart-XT-Link6 is designed to provide both qualitative and quantitative information.… | 2014 |
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 25 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All JOP devicesJOP Transducer, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · JOP
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JOP
Too few JOP 510(k)s in any year since 2007 to give a median.
Recalls per year · JOP
No recall names JOP since 2007.
Adverse event reports per year · JOP
2in 2025
MAUDE reports naming product code JOP, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Smartdop XT6 is intended for use in the non-invasive evaluation of peripheral vascular pathology in patients. It detects systolic pressures for ankle-brachial index (ABI), toe-brachial index (TBI), and arterial and venous blood flow in extremities. Measurements are provided utilizing cuffs, photoplethysmography (PPG) and/or Doppler probe. The optional foot temperature probe provides skin temperature readings on the foot. Collected data is captured…
Read the full statement (113 words)
The Smartdop XT6 is intended for use in the non-invasive evaluation of peripheral vascular pathology in patients. It detects systolic pressures for ankle-brachial index (ABI), toe-brachial index (TBI), and arterial and venous blood flow in extremities. Measurements are provided utilizing cuffs, photoplethysmography (PPG) and/or Doppler probe. The optional foot temperature probe provides skin temperature readings on the foot. Collected data is captured and stored with Smart-XT-Link6 software that includes capabilities to print waveforms and export to into the facility's electronic health records.
It is not intended to be used in fetal applications or used inside the sterile field. It is intended to be used by licensed healthcare practitioners on adults and pediatrics only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153762: Smartdop XT6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153762
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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