510(k) · Cleared
ClearedSmartdop 45 Vascular Doppler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Koven Technology, Inc. · DPW Flowmeter, Blood, Cardiovascular
Cleared on Apr 15, 2005 as substantially equivalent to K954397 (Koven Technology, Inc., 1996) after a 37-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.
- Decided
- Apr 15, 2005
- Review
- 37 days
- Class
- Class II
- Product code
- DPW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954397 (1996). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK954397 Bidirectional Doppler W/Waveform DisplayKoven Technology, Inc. · 1996 · Recalled
- This deviceK050601 Smartdop 45 Vascular DopplerKoven Technology, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK201114 Bidop 7Koven Technology, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK121267 BT-200V Vascular DopplerBistos Co., Ltd. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954397 | Bidirectional Doppler W/Waveform Display | Koven Technology, Inc. | 1996 | 1 |
| 0 (this device) | K050601 | Smartdop 45 Vascular Doppler | Koven Technology, Inc. | 2005 | — |
| +1 | K201114 | Bidop 7 | Koven Technology, Inc. | 2021 | — |
| +1 | K121267 | BT-200V Vascular Doppler | Bistos Co., Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2021 | 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 DPW? 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 DPW device
- #1 K251114 FloPatch FP120score 13.7 · 5 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 |
|---|---|---|---|
| * | K954397 | Bidirectional Doppler W/Waveform DisplaySummary page 1…meter, Cardiovascular 3. Predicate Device: Bidirectional Doppler WlWaveform Display, Smartdop 50 Koven Technology, Inc., K954397, 870-2100, DPW, Cardiovascular & Radiology 4. Classifications Names & Citations:… | 1996 |
What descends from it? (2)
2 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?
- Its one ancestor has a recall.
- Of its descendants, K201114 (Koven Technology, Inc., 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DPW devicesDPW Flowmeter, Blood, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DPW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPW
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPW
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DPW
6in 2025
MAUDE reports naming product code DPW, 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 | — | 4 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 2 | — | 1 | 0 |
| 2011 | 4 | 89 | 0 | 1 |
| 2012 | 1 | — | 1 | 0 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 3 | 275 | 0 | 12 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 3 | 169 | 0 | 3 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 3 | 136 | 0 | 1 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 3 | 119 | 1 | 6 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Smartdop 45 detects arterial and venous blood flow in extremities as well as fetal heart sounds. The Smartdop 45 displays and prints bi-directional velocity waveform, numerical data and fetal heart rate with heart beat indicator. The Smartdop 45 probe selection is 2, 4, 5, 8 and 10 MHz.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050601 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050601: Smartdop 45 Vascular Doppler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050601
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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