510(k) · Cleared
Recalled · Class II · 2014Vti Intraoperative Doppler Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Technology Incorporated · DPW Flowmeter, Blood, Cardiovascular
Cleared on Oct 28, 2008 after a 29-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 28, 2008
- Review
- 29 days
- Class
- Class II
- Product code
- DPW
- Recalls
- 4
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK082870 Vti Intraoperative Doppler SystemsVascular Technology Incorporated · 2008
- Descendant · cites it directly · 3 of its ownK212065 VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe…Remington Medical, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK211589 VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe…Remington Medical, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK241583 VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe…Remington Medical, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK260700 BlueDop Vascular ExpertBlueDop Medical, Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK251904 VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe…Remington Medical, Inc. · 2025
Most influential descendants
Showing 5 of 5 · See all- K212065VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek ChargerRemington Medical, Inc. · 2021 · cites it directly3descendants
- K211589VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek ChargerRemington Medical, Inc. · 2022 · cites it directly2descendants
- K241583VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger…Remington Medical, Inc. · 2024 · 2 generations on1descendant
- K260700BlueDop Vascular ExpertBlueDop Medical, Ltd. · 2026 · 2 generations on0descendants
- K251904VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock…Remington Medical, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082870 | Vti Intraoperative Doppler Systems | Vascular Technology Incorporated | 2008 | — |
| +1 | K212065 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek… | Remington Medical, Inc. | 2021 | — |
| +1 | K211589 | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek… | Remington Medical, Inc. | 2022 | — |
| +2 | K241583 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek… | Remington Medical, Inc. | 2024 | — |
| +2 | K260700 | BlueDop Vascular Expert | BlueDop Medical, Ltd. | 2026 | — |
| +3 | K251904 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek… | Remington Medical, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 28, 2014 | Class II | Z-2000-2014 | Process design | Report of the product penetrating the sterile barrier; this could render the product unsterile. |
| May 28, 2014 | Class II | Z-1998-2014 | Process design | Report of the product penetrating the sterile barrier; this could render the product unsterile. |
| May 28, 2014 | Class II | Z-1999-2014 | Process design | Report of the product penetrating the sterile barrier; this could render the product unsterile. |
| May 28, 2014 | Class II | Z-2001-2014 | Process design | Report of the product penetrating the sterile barrier; this could render the product unsterile. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K212065 (Remington Medical, Inc., 2021) has gone furthest, with 3 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. 2008, 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 VTI Intraoperative Doppler Systems are intended for the intraoperative and transcutaneous evaluation of blood flow.
Indications for Use form filed with the FDA for the VTI Doppler Probes lists the clinical applications as Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K082870 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082870: Vti Intraoperative Doppler Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082870
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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