510(k) Report

510(k) · Cleared

Cleared

VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)

K251904510(k) TraditionalCleared Nov 20, 2025153-day reviewClass II21 CFR 870.2100

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Remington Medical, Inc. · DPW Flowmeter, Blood, Cardiovascular

Cleared on Nov 20, 2025 as substantially equivalent to K241583 (Remington Medical, Inc., 2024) after a 153-day review. Its family tree reaches back 3 generations to 2008.

Decided
Nov 20, 2025
Review
153 days
Class
Class II
Product code
DPW
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K082870 (2008). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2022: 1 other ancestorReference device: K827296 · Polysonic Ultrasound Lotion · Parker Laboratories, Inc. · 1982K082870 · Vti Intraoperative Doppler Systems · Vascular Technology Incorporated · 2008 · recalledK212065 · VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger · Remington Medical, Inc. · 2021K241583 · 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) · Remington Medical, Inc. · 202420052010201520202025
Other ancestors, by generation 2 generations back: 1 other ancestor 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) · Remington Medical, Inc. · 2024K212065 · VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger · Remington Medical, Inc. · 2021K082870 · Vti Intraoperative Doppler Systems · Vascular Technology Incorporated · 2008 · recalled0
  1. Root · 3 generations backK082870 Vti Intraoperative Doppler SystemsVascular Technology Incorporated · 2008 · Recalled
  2. 2 generations backK212065 VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe…Remington Medical, Inc. · 2021
  3. 1 generation backK241583 VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe…Remington Medical, Inc. · 2024
  4. This deviceK251904 VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe…Remington Medical, Inc. · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K082870Vti Intraoperative Doppler SystemsVascular Technology Incorporated20084
−2K212065VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek…Remington Medical, Inc.2021—
−1K241583VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek…Remington Medical, Inc.2024—
0 (this device)K251904VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek…Remington Medical, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
202210
FIG. 1 — Lineage of K251904, 2008–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251114 FloPatch FP120score 13.7 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K241583VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger…
Summary page 5
…Flowmeter, Blood, Cardiovascular Classification 21 CFR §870.2100 Cardiovascular blood flowmeter Name Product Code: DPW Device Class II K241583 Remington Medical, Inc. VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KI…
Remington Medical, Inc.2024—
†K827296Polysonic Ultrasound LotionParker Laboratories, Inc.1982—

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 17 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
  • 1 of the 4 ancestors has a recall of any class.

How does its category compare?

All DPW devices

DPW Flowmeter, Blood, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · DPW

3in 2025

2007: 12008: 12010: 22011: 42012: 12013: 22015: 32016: 12018: 22019: 32020: 22021: 22022: 32023: 12024: 12025: 32026 (partial year): 2
2007high 4 (2011) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DPW

119in 2025

2011: 89 days median2015: 275 days median2019: 169 days median2022: 136 days median2025: 119 days median
2007high 275 (2015) · low 89 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DPW

1in 2025

2007: 42010: 12012: 12017: 12025: 1
2007high 4 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DPW

6in 2025

2009: 12011: 12013: 32014: 82015: 122016: 12017: 22019: 32020: 42021: 62022: 12023: 22024: 42025: 6
2007high 12 (2015) · low 0 (2007)2025

MAUDE reports naming product code DPW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—40
20081—00
20090—01
20102—10
201148901
20121—10
20132—03
20140—08
20153275012
20161—01
20170—12
20182—00
2019316903
20202—04
20212—06
2022313601
20231—02
20241—04
2025311916
20262—0—

What is it indicated for?

VascuChek® Kit, VascuChek® Transceiver, VascuChek® Clinical Probe, VascuChek® Speaker Dock:

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® Speaker Dock:

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.

More from Remington Medical, Inc.

19 FDA decisions under this applicant name. See the company

  • K241583VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01…Remington Medical, Inc. · 2024
  • K211589VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek ChargerRemington Medical, Inc. · 2022
  • K212065VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek ChargerRemington Medical, Inc. · 2021
  • K191315Remington Medical, Inc. Automatic Cutting Needle (NAC)Remington Medical, Inc. · 20191 recall
  • K150266Remington Medical Inc. Tuohy Epidural NeedlesRemington Medical, Inc. · 2015

Recent decisions in DPW

The DPW category page

  • K260700BlueDop Vascular ExpertBlueDop Medical, Ltd. · 2026
  • K252810FloPatch FP120Flosonics Medical · 2026
  • K251114FloPatch FP120Flosonics Medical · 2025
  • K243852Elfor-LElfi-Tech, Ltd. · 2025
  • K241583VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01…Remington Medical, Inc. · 2024

https://510kreport.com/device/K251904 · printed Nov 5, 2026

Cite this page

510(k) Report. “K251904: VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251904

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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