510(k) · Cleared
ClearedVascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Remington Medical, Inc. · DPW Flowmeter, Blood, Cardiovascular
Cleared on Oct 7, 2021 as substantially equivalent to K082870 (Vascular Technology Incorporated, 2008) after a 97-day review. Its family tree reaches back 1 generation to 2008. 3 later devices descend from it.
- Decided
- Oct 7, 2021
- Review
- 97 days
- Class
- Class II
- Product code
- DPW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K082870 (2008). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK082870 Vti Intraoperative Doppler SystemsVascular Technology Incorporated · 2008 · Recalled
- This deviceK212065 VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe…Remington Medical, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK241583 VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe…Remington Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK260700 BlueDop Vascular ExpertBlueDop Medical, Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK251904 VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe…Remington Medical, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See all- K241583VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger…Remington Medical, Inc. · 2024 · cites it directly1descendant
- K260700BlueDop Vascular ExpertBlueDop Medical, Ltd. · 2026 · cites it directly0descendants
- K251904VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock…Remington Medical, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K082870 | Vti Intraoperative Doppler Systems | Vascular Technology Incorporated | 2008 | 4 |
| 0 (this device) | K212065 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek… | Remington Medical, Inc. | 2021 | — |
| +1 | K241583 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek… | Remington Medical, Inc. | 2024 | — |
| +1 | K260700 | BlueDop Vascular Expert | BlueDop Medical, Ltd. | 2026 | — |
| +2 | 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 |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K082870 | Vti Intraoperative Doppler SystemsSummary page 4…n Name Product Code: DPW Device Class: II Predicate Device: Vascular Technology Incorporated (VTI) Surgical Doppler (K082870) Description of the Device: VascuChek™ is a cardiovascular blood flowmeter comprised of two components: a nonsterile,… | 2008 |
What descends from it? (3)
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?
How does its category compare?
All DPW devicesDPW Flowmeter, Blood, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Remington Medical, Inc. VascuChek™ Clinical Device is intended for the non-invasive transcutaneous evaluation of blood flow in Peripheral Vasculature.
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/K212065 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212065: VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212065
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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