Quantum Workstation 12.1
FDA 510(k) K181923 · Spectrum Medical , Ltd.
510(k) numberK181923
Submission
- Device name
- Quantum Workstation 12.1
- Applicant
- Spectrum Medical , Ltd.
Gloucester, GB - Received
- July 18, 2018
- Decision date
- August 17, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRY – Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4330
- Specialty
- Cardiovascular
Other 510(k)s with product code DRY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K234065 | CDI OneView Monitoring SystemDRY · Traditional | Terumo Cardiovascular Systems Corporation | 04/25/2024SE |
| K202154 | B-CaptaDRY · Traditional | Livanova Deutschland, GmbH | 04/01/2021SE |
| K202557 | Quantum Workstation 12 EliteDRY · Special | Spectrum Medical , Ltd. | 10/02/2020SE |
| K182110 | CDI Blood Parameter Monitoring System 550DRY · Traditional | Terumo Cardiovascular Systems Corporation | 11/02/2018SE |
| K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No GasDRY · Traditional | Spectrum Medical , Ltd. | 03/28/2018SE |
| K163657 | Quantum WorkstationDRY · Special | Spectrum Medical , Ltd. | 01/18/2017SE |
| K133157 | Tri-Optic Measurement Cell; with Balance Biosurface, with Carmeda Bioactive Surface…DRY · Traditional | Medtronic, Inc. | 10/23/2014SE |
| K133658 | Cdi Blood Parameter Monitoring System 500DRY · Traditional | Terumo Cardiovascular Systems Corp. | 07/25/2014SE |
| K123039 | Cdi Blood Parameter Monitoring System 500DRY · Traditional | Terumo Cardiovascular Systems Corp. | 11/20/2012SE |
| K110957 | M4 MonitorDRY · Traditional | Spectrum Medical, Llp | 05/31/2011SE |
More from Spectrum Medical, Llp
| 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 |
| K202733 | Quantum Ventilation ModuleDTX · Special | 10/16/2020SE |
| 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 |
| 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 Workstation 12.1 cleared by the FDA?
Quantum Workstation 12.1 (K181923) received a 510(k) decision of Substantially Equivalent on August 17, 2018, 30 days after the submission was received.
What is the product code of K181923?
The FDA product code is DRY – Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4330.