510(k) · Cleared
ClearedBlueDop Vascular Expert
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BlueDop Medical, Ltd. · DPW Flowmeter, Blood, Cardiovascular
Cleared on Jul 8, 2026 as substantially equivalent to K212065 (Remington Medical, Inc., 2021) after a 126-day review. Its family tree reaches back 2 generations to 2008.
- Decided
- Jul 8, 2026
- Review
- 126 days
- Class
- Class II
- Product code
- DPW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K082870 (2008). No later device cites it as a predicate yet.
- Root · 2 generations backK082870 Vti Intraoperative Doppler SystemsVascular Technology Incorporated · 2008 · Recalled
- 1 generation backK212065 VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe…Remington Medical, Inc. · 2021
- This deviceK260700 BlueDop Vascular ExpertBlueDop Medical, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K082870 | Vti Intraoperative Doppler Systems | Vascular Technology Incorporated | 2008 | 4 |
| −1 | K212065 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek… | Remington Medical, Inc. | 2021 | — |
| 0 (this device) | K260700 | BlueDop Vascular Expert | BlueDop Medical, Ltd. | 2026 | — |
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 |
|---|---|---|---|
| * | K212065 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek ChargerSummary page 5…ate Device Predicate Device: VascuChek Clinical Device Sponsor Remington Medical, Inc. 510(K) K212065 Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flow Meter Product… | 2021 |
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 18 years and passes through 3 companies; a new generation was cleared every 12.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K212065.
How does its category compare?
All DPW devicesDPW Flowmeter, Blood, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
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 BlueDop Vascular Expert (BVE) is intended to non-invasively detect the presence of blood flow in peripheral arteries using Doppler ultrasound technology. The device provides Doppler waveform information to support clinical evaluation of peripheral vascular status.
The BVE is intended to be used as an adjunct to standard clinical assessment and does not provide a standalone diagnostic determination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260700 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260700: BlueDop Vascular Expert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260700
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026