Quantum Ventilation Module
FDA 510(k) K202733 · Spectrum Medical , Ltd.
510(k) numberK202733
Submission
- Device name
- Quantum Ventilation Module
- Applicant
- Spectrum Medical , Ltd.
Gloucester, GB - Received
- September 18, 2020
- Decision date
- October 16, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTX – Gas Control Unit, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4300
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code DTX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K210669 | Quantum Mini Ventilation ModuleDTX · Traditional | Spectrum Medical , Ltd. | 05/04/2021SE |
| K181942 | Quantum Ventilation ModuleDTX · Traditional | Spectrum Medical , Ltd. | 10/18/2018SE |
| K101046 | Stockert S5 System and Gas Blender and Sorin C5 SystemDTX · Traditional | Sorin Group Deutschland GmbH | 12/09/2010SE |
| K023745 | Sechrist Air/Oxygen Mixer, Model 3500 Cp-GDTX · Traditional | Sechrist Industries, Inc. | 01/17/2003SE |
| K965214 | Coeur Front Load Injector Retrofit Kit (C859-0002)DTX · Traditional | Coeur Laboratories, Inc. | 03/28/1997SE |
| K863902 | Modified Sarns Membrane OxygenatorDTX · Traditional | 3M Health Care, Sarns | 12/11/1986SE |
| K822820 | Gas-Flow Meter GFL 10DTX · Traditional | Gambro, Inc. | 10/18/1982SE |
| K792348 | Stanicor, Omni-Stan,Mod 333B,334A GammaDTX · Traditional | Cordis Corp. | 12/05/1979SE |
| K790546 | Flowmeter, Optiflo GasDTX · Traditional | Cobe Laboratories, Inc. | 05/11/1979SE |
More from Cobe Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K240908 | Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module…DTR · Traditional | 07/08/2025SE |
| K212657 | Quantum Heater-CoolerDWC · Traditional | 05/06/2022SE |
| K210669 | Quantum Mini Ventilation ModuleDTX · Traditional | 05/04/2021SE |
| K202557 | Quantum Workstation 12 EliteDRY · Special | 10/02/2020SE |
| K192838 | Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium PressureDWA · Traditional | 04/13/2020SE |
| K190282 | Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)DTQ · Traditional | 05/24/2019SE |
| K181942 | Quantum Ventilation ModuleDTX · Traditional | 10/18/2018SE |
| K181923 | Quantum Workstation 12.1DRY · Special | 08/17/2018SE |
| K173834 | Quantum Pump ConsoleDTQ · Traditional | 05/25/2018SE |
| K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No GasDRY · Traditional | 03/28/2018SE |
Questions and answers
When was Quantum Ventilation Module cleared by the FDA?
Quantum Ventilation Module (K202733) received a 510(k) decision of Substantially Equivalent on October 16, 2020, 28 days after the submission was received.
What is the product code of K202733?
The FDA product code is DTX – Gas Control Unit, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4300.