Quadrox-Ir Adult and Small Adult
FDA 510(k) K133265 · Maquet Cardiopulmonary, AG
510(k) numberK133265
Submission
- Device name
- Quadrox-Ir Adult and Small Adult
- Applicant
- Maquet Cardiopulmonary, AG
Wayne, NJ, US - Received
- October 23, 2013
- Decision date
- November 12, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KFM – Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4360
- Specialty
- Cardiovascular
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251762 | Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)KFM · Traditional | Spectrum Medical S.R.L. | 08/04/2025SE |
| K250326 | Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)KFM · Traditional | Spectrum Medical S.R.L. | 06/24/2025SE |
| K233091 | Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT)…KFM · Special | Qura S.R.L | 10/26/2023SE |
| K232132 | LifeSPARC SystemKFM · Special | Cardiacassist, Inc. | 08/03/2023SE |
| K220842 | Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion…KFM · Traditional | Qura S.R.L | 05/19/2023SE |
| K200091 | Capiox iCP Centrifugal PumpKFM · Traditional | Terumo Cardiovascular Systems Corporation | 11/18/2021SE |
| K201320 | Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated SensorKFM · Traditional | Qura S.R.L | 11/03/2021SE |
| K193663 | FloPump 57mL Centrifugal PumpKFM · Traditional | International Biophysics Corporation | 03/10/2021SE |
| K202169 | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22KFM · Special | Qura S.R.L | 09/02/2020SE |
| K201068 | Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance…KFM · Special | Medtronic, Inc. | 05/21/2020SE |
More from Medtronic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K150267 | QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult OxygenatorsDTZ · Traditional | 05/07/2015SE |
| K140569 | Antegrade Cardioplegia Cannula(N-Type)DWF · Traditional | 11/19/2014SE |
| K141432 | Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy…DTN · Special | 07/07/2014SE |
| K133598 | Cardiohelp SystemDTQ · Traditional | 05/21/2014SE |
| K132166 | Venous Hardshell Cardiotomy Reservoir; Non-Coated, Non-Tight/ Vacuum-Tight/ with…DTN · Special | 10/30/2013SE |
| K132829 | Quadrox-I, Quadrox-Id, Quadrox-Ir OxygenatorsDTZ · Special | 10/08/2013SE |
| K131666 | Arterial HLS Cannula 13 FR Non-Coated, with Bioline Coating and with Softline CoatingDWF · Special | 07/05/2013SE |
| K130300 | Heater-Cooler Unit Hcu 40DWC · Traditional | 07/01/2013SE |
| K123288 | HemoconcentratorKDI · Traditional | 06/26/2013SE |
| K130639 | Elite-I (Bi) Dual Lumen Catheter; Elite-I (Ra) Dual Lumen Catheter; Elite-I (Bix)Dual…DWF · Special | 05/16/2013SE |
Questions and answers
When was Quadrox-Ir Adult and Small Adult cleared by the FDA?
Quadrox-Ir Adult and Small Adult (K133265) received a 510(k) decision of Substantially Equivalent on November 12, 2013, 20 days after the submission was received.
What is the product code of K133265?
The FDA product code is KFM – Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type, a Class II (moderate risk) device regulated under 21 CFR 870.4360.