Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Exchange Disposable Set
FDA 510(k) K132429 · Terumobct, Inc.
510(k) numberK132429
Submission
- Device name
- Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Exchange Disposable Set
- Applicant
- Terumobct, Inc.
Lakewood, CO, US - Received
- August 5, 2013
- Decision date
- December 6, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LKN – Separator, Automated, Blood Cell And Plasma, Therapeutic
- Device class
- Unclassified
Other 510(k)s with product code LKN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K192150 | AMICUS Separator SystemLKN · Traditional | Fresenius Kabi AG | 11/13/2019SE |
| K183081 | Spectra Optia Apheresis SystemLKN · Traditional | Terumobct, Inc. | 02/05/2019SE |
| K180615 | AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood…LKN · Traditional | Fresenius Kabi USA,Llc | 12/04/2018SE |
| K181049 | Spectra Optia Apheresis SystemLKN · Special | Terumobct, Inc. | 11/01/2018SE |
| K172590 | Spectra Optia Apheresis SystemLKN · Traditional | Terumobct, Inc. | 03/02/2018SE |
| K153601 | Spectra Optia Apheresis SystemLKN · Special | Terumobct, Inc. | 01/14/2016SE |
| K151368 | Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra…LKN · Traditional | Terumo Bct | 09/11/2015SE |
| K141938 | Spectra Optia Apheresis System, Spectra Optia Exchange Set (Disposable Blood Tubing Set)LKN · Traditional | Terumobct, Inc. | 03/23/2015SE |
| K141019 | Amicus Separator System/ Amicus Seperator System;RefurbishedLKN · Traditional | Fenwal, Inc. | 06/10/2014SE |
| K131744 | Spectra Optia Apheresis System, Spectra Optia Single-Needle Connector, Spectra Optia…LKN · Traditional | Terumobct, Inc. | 08/08/2013SE |
More from Terumobct, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K183081 | Spectra Optia Apheresis SystemLKN · Traditional | 02/05/2019SE |
| K181049 | Spectra Optia Apheresis SystemLKN · Special | 11/01/2018SE |
| K172590 | Spectra Optia Apheresis SystemLKN · Traditional | 03/02/2018SE |
| K162365 | T-CuffKCY · Traditional | 02/16/2017SE |
| K153601 | Spectra Optia Apheresis SystemLKN · Special | 01/14/2016SE |
| K141938 | Spectra Optia Apheresis System, Spectra Optia Exchange Set (Disposable Blood Tubing Set)LKN · Traditional | 03/23/2015SE |
| K131744 | Spectra Optia Apheresis System, Spectra Optia Single-Needle Connector, Spectra Optia…LKN · Traditional | 08/08/2013SE |
Questions and answers
When was Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Exchange Disposable Set cleared by the FDA?
Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Exchange Disposable Set (K132429) received a 510(k) decision of Substantially Equivalent on December 6, 2013, 123 days after the submission was received.
What is the product code of K132429?
The FDA product code is LKN – Separator, Automated, Blood Cell And Plasma, Therapeutic, a Unclassified device.