510(k) · Cleared
ClearedVascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)
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 Aug 30, 2024 as substantially equivalent to K211589 (Remington Medical, Inc., 2022) and 1 other predicate after an 88-day review. Its family tree reaches back 2 generations to 2008. 1 later device descends from it.
- Decided
- Aug 30, 2024
- Review
- 88 days
- Class
- Class II
- Product code
- DPW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K082870 (2008). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK241583 VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe…Remington Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK251904 VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe…Remington Medical, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251904VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock…Remington Medical, Inc. · 2025 · cites it directly0descendants
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) | K241583 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek… | Remington Medical, Inc. | 2024 | — |
| +1 | K251904 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek… | Remington Medical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K211589 | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek ChargerSummary page 5…Flowmeter, Blood, Cardiovascular Classification 21 CFR §870.2100 Cardiovascular blood flowmeter Name Product Code: DPW Device Class II K211589 Remington Medical, Inc. VascuChek Kit, VascuChek Transceiver, Predicate VascuChek Surgical Probe, VascuChek Charger Device… | 2022 |
| * | K212065 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek ChargerSummary page 5…II K211589 Remington Medical, Inc. VascuChek Kit, VascuChek Transceiver, Predicate VascuChek Surgical Probe, VascuChek Charger Devices K212065 Remington Medical, Inc. VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger Device… | 2021 |
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 |
|---|---|---|---|
| K251904 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock… | 2025 | 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 16 years and passes through 2 companies; a new generation was cleared every 12.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K251904 (Remington Medical, Inc., 2025) 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. 2024, 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?
VascuChek® Kit, VascuChek® Transceiver, VascuChek® Clinical Probe, VascuChek® Charger:
The VascuChek® device is intended for the non-invasive transcutaneous evaluation of blood flow in Peripheral Vasculature.
VascuChek® Kit, VascuChek® Transceiver, VascuChek® Surgical Probe, VascuChek® Charger:
The VascuChek® device is intended for the intraoperative and transcutaneous evaluation of blood flow in the following clinical applications:
- Intraoperative (Microvascular and Vascular)
- Intraoperative Neurological
- Transrectal and Peripheral Vascular.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241583 · printed Nov 4, 2026
Cite this page
510(k) Report. “K241583: VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K241583
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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