510(k) · Cleared
ClearedSmartdop XT
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 Jan 17, 2014 as substantially equivalent to K111416 (Viasonix, Ltd., 2011) after a 227-day review. Its family tree reaches back 2 generations to 1991. 1 later device descends from it.
- Decided
- Jan 17, 2014
- Review
- 227 days
- Class
- Class II
- Product code
- JOP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K904392 (1991). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K153762Smartdop XT6Koven Technology, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904392 | Multilab 2000 | Unetixs, Inc. | 1991 | 4 |
| −1 | K111416 | Falcon | Viasonix, Ltd. | 2011 | — |
| 0 (this device) | K131623 | Smartdop XT | Koven Technology, Inc. | 2014 | — |
| +1 | K153762 | Smartdop XT6 | Koven Technology, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | K111416 | FalconSummary page 1…sive evaluation of peripheral vascular pathology now in market. The predicate device is the Falcon/Pro manufactured by Viasonix Ltd,, Rammana, Israel, with S.E number of K1 11416. Device description: The Smartdlop XT with Smart-XT-Link is designed to provide both qualitative and quantitative information.… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153762 | Smartdop XT6 | 2016 | 0 |
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 23 years and passes through 3 companies; a new generation was cleared every 20.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K153762 (Koven Technology, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K111416.
How does its category compare?
All JOP devicesJOP Transducer, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 XT 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 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-Link 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131623: Smartdop XT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131623
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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