Smartdop 20 Bi-Directional Blood Flow Detector
FDA 510(k) K920333 · Koven and Assoc., Inc.
510(k) numberK920333
Submission
- Device name
- Smartdop 20 Bi-Directional Blood Flow Detector
- Applicant
- Koven and Assoc., Inc.
St. Louis, MO, US - Received
- January 27, 1992
- Decision date
- January 22, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2100
- Specialty
- Cardiovascular
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| 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 |
| K211589 | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek ChargerDPW · Traditional | Remington Medical, Inc. | 01/27/2022SE |
More from Remington Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K922669 | Multidop Model HD-2020 Bi-Directional Blood FlowDPW · Traditional | 01/29/1993SE |
| K915550 | Mini Doppler II Ultrasound Blood Flow DetectorDPW · Traditional | 12/10/1992SE |
| K913595 | DS-240 Ambulatory Blood Pressure Monitoring SystemDXN · Traditional | 03/27/1992SE |
| K912409 | Model HD-207 Bidirectional Velocity MeterJOP · Traditional | 12/23/1991SE |
| K903026 | ES-1000SP II Smart DopDPW · Traditional | 02/26/1991SE |
| K894892 | HD-2200 Pneumo-Dop Vascular Testing SystemDSB · Traditional | 10/27/1989SE |
| K892707 | DVM-4200 Blood FlowmeterDPW · Traditional | 07/28/1989SE |
Questions and answers
When was Smartdop 20 Bi-Directional Blood Flow Detector cleared by the FDA?
Smartdop 20 Bi-Directional Blood Flow Detector (K920333) received a 510(k) decision of Substantially Equivalent on January 22, 1993, 361 days after the submission was received.
What is the product code of K920333?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.