Stockert 1/4 Bubble Sensor
FDA 510(k) K925541 · Sorin Biomedica, Fiat, USA, Inc.
510(k) numberK925541
Submission
- Device name
- Stockert 1/4 Bubble Sensor
- Applicant
- Sorin Biomedica, Fiat, USA, Inc.
Irvine, CA, US - Received
- November 3, 1992
- Decision date
- February 2, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRL – Detector, Bubble, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4205
- Specialty
- Cardiovascular
Other 510(k)s with product code KRL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K103469 | Stockert Air Purge Control System Model 23-45-05KRL · Traditional | Sorin Group Deutschland GmbH | 01/18/2011SE |
| K090698 | Capiox Bubble Trap with X-CoatingKRL · Traditional | Terumo Cardiovascular Systems | 06/08/2009SE |
| K071231 | Edac QuantifierKRL · Traditional | Luna Innovations, Inc. | 05/17/2007SE |
| K961364 | Automatic Tubing Clamp System (Atc)KRL · Traditional | Rocky Mountain Research, Inc. | 10/31/1996SE |
| K961598 | Els Automatic Tubing Clamp SystemKRL · Traditional | Rocky Mountain Research, Inc. | 10/29/1996SE |
| K940651 | Sarns Ultrasonic Air SensorKRL · Traditional | 3M Health Care, Sarns | 05/24/1994SE |
| K935977 | Sarns Air Detection SystemKRL · Traditional | 3M Health Care, Sarns | 02/04/1994SE |
| K925661 | Stockert CAPS1 Cardioplegic Control ModuleKRL · Traditional | Sorin Biomedica, Fiat, USA, Inc. | 05/18/1993SE |
| K911632 | Capiox(R) Bubble TrapKRL · Traditional | Terumo Medical Corp. | 07/09/1991SE |
| K864619 | Caps Low Level Detector & Detector/Bubble MonitorKRL · Traditional | Shiley, Inc. | 02/03/1987SE |
More from Shiley, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K931444 | Plexus 2 & 3.5 Hollow Fiber OxygenatorsDTZ · Traditional | 05/27/1994SE |
| K925661 | Stockert CAPS1 Cardioplegic Control ModuleKRL · Traditional | 05/18/1993SE |
| K925615 | Shiley Specialized,Pediatric & Neonatal Trach.TubeCBI · Traditional | 03/26/1993SE |
| K925369 | BCD Advanced Blood Carioplegia SystemsDTR · Traditional | 03/26/1993SE |
| K924354 | Stockert Caps Low Level Detect Ii/Bubble MonitorDTW · Traditional | 02/18/1993SE |
| K922933 | Sorin Monolyrh Integrated Membrane LungDTZ · Traditional | 11/30/1992SE |
| K854963 | S80 Implantable Cardiac Pacing LeadDTB · Traditional | 06/24/1986SE |
| K852641 | Orion 40 Cardiac Stimulator & PMP 200 ProgrammerDXY · Traditional | 01/14/1986SE |
| K851365 | Sorin Biomedica Orion 30/A Cardiac Stimulator & PMDXY · Traditional | 12/03/1985SE |
| K841948 | Testosterone Direct RadioimmunoassayCDZ · Traditional | 06/25/1984SE |
Questions and answers
When was Stockert 1/4 Bubble Sensor cleared by the FDA?
Stockert 1/4 Bubble Sensor (K925541) received a 510(k) decision of Substantially Equivalent on February 2, 1993, 91 days after the submission was received.
What is the product code of K925541?
The FDA product code is KRL – Detector, Bubble, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4205.