Sensilase Pad 3000
FDA 510(k) K040654 · Optical Sensors, Inc.
510(k) numberK040654
Submission
- Device name
- Sensilase Pad 3000
- Applicant
- Optical Sensors, Inc.
Stoughton, WI, US - Received
- March 12, 2004
- Decision date
- June 4, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
| 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 |
|---|---|---|
| K010795 | Capnoprobe SL, Model 2000CCK · Special | 04/11/2001SE |
| K984579 | Capno Probe aCCK · Traditional | 12/21/2000SE |
| K961790 | Point-Of-Care Blood Gas Monitor SystemCCC · Traditional | 04/09/1997SE |
| K963935 | Olympus Critical Care Monitoring SystemCCC · Traditional | 01/23/1997SE |
| K951094 | Point-Of-Care Arterial Blood Gas Monitoring SystemCCC · Traditional | 01/16/1996SE |
| K931185 | Sensicath Point-Of-Care Blood Gas Monitoring SysteCCC · Traditional | 10/21/1993SE |
Questions and answers
When was Sensilase Pad 3000 cleared by the FDA?
Sensilase Pad 3000 (K040654) received a 510(k) decision of Substantially Equivalent on June 4, 2004, 84 days after the submission was received.
What is the product code of K040654?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.