Critiview
FDA 510(k) K051145 · Critisense , Ltd.
510(k) numberK051145
Submission
- Device name
- Critiview
- Applicant
- Critisense , Ltd.
Mccordsville, IN, US - Received
- May 4, 2005
- Decision date
- January 18, 2006
- 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
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|---|---|---|---|
| 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 |
| 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 |
|---|---|---|
| K062977 | Critiview, Model CRV3DPW · Traditional | 02/28/2007SE |
Questions and answers
When was Critiview cleared by the FDA?
Critiview (K051145) received a 510(k) decision of Substantially Equivalent on January 18, 2006, 259 days after the submission was received.
What is the product code of K051145?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.