VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger
FDA 510(k) K211589 · Remington Medical, Inc.
510(k) numberK211589
Submission
- Device name
- VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger
- Applicant
- Remington Medical, Inc.
Alpharetta, GA, US - Received
- May 24, 2021
- Decision date
- January 27, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2100
- Specialty
- Cardiovascular
Other 510(k)s with product code DPW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260700 | BlueDop Vascular ExpertDPW · Traditional | BlueDop Medical, Ltd. | 07/08/2026SE |
| K252810 | FloPatch FP120DPW · Special | Flosonics Medical | 04/24/2026SE |
| K251904 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock…DPW · Traditional | Remington Medical, Inc. | 11/20/2025SE |
| K251114 | FloPatch FP120DPW · Traditional | Flosonics Medical | 06/20/2025SE |
| K243852 | Elfor-LDPW · Traditional | Elfi-Tech , Ltd. | 04/14/2025SE |
| K241583 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger…DPW · Special | Remington Medical, Inc. | 08/30/2024SE |
| K223843 | FloPatch FP120DPW · Traditional | Flosonics Medical | 05/03/2023SE |
| K222242 | FloPatch FP120DPW · Traditional | Flosonics Medical | 12/09/2022SE |
| K213974 | GEM FLOW COUPLER Monitor (GEM1020M-2)DPW · Special | Synovis Micro Companies Alliance, Inc. | 04/20/2022SE |
| K212065 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek ChargerDPW · Traditional | Remington Medical, Inc. | 10/07/2021SE |
More from Remington Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251904 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock…DPW · Traditional | 11/20/2025SE |
| K241583 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger…DPW · Special | 08/30/2024SE |
| K212065 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek ChargerDPW · Traditional | 10/07/2021SE |
| K191315 | Remington Medical, Inc. Automatic Cutting Needle (NAC)KNW · Traditional | 07/12/2019SE |
| K150266 | Remington Medical Inc. Tuohy Epidural NeedlesBSP · Traditional | 06/04/2015SE |
| K130282 | Remington Medical Centrefire 22 Biopsy InstrumentKNW · Traditional | 05/13/2013SE |
| K050884 | Adapter CableDTA · Traditional | 05/19/2005SE |
| K040266 | Core Needle BiopsyKNW · Traditional | 07/09/2004SE |
| K990428 | Drainage BagEXF · Traditional | 08/12/1999SE |
| K983621 | Needle GuideIZH · Traditional | 11/03/1998SE |
Questions and answers
When was VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger cleared by the FDA?
VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (K211589) received a 510(k) decision of Substantially Equivalent on January 27, 2022, 248 days after the submission was received.
What is the product code of K211589?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.