Spectra Optia Apheresis System
FDA 510(k) K181049 · Terumobct, Inc.
510(k) numberK181049
Submission
- Device name
- Spectra Optia Apheresis System
- Applicant
- Terumobct, Inc.
Lakewood, CO, US - Received
- April 20, 2018
- Decision date
- November 1, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
| K132429 | Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Exchange…LKN · Traditional | Terumobct, Inc. | 12/06/2013SE |
| 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 |
| 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 |
| K132429 | Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Exchange…LKN · Traditional | 12/06/2013SE |
| 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 cleared by the FDA?
Spectra Optia Apheresis System (K181049) received a 510(k) decision of Substantially Equivalent on November 1, 2018, 195 days after the submission was received.
What is the product code of K181049?
The FDA product code is LKN – Separator, Automated, Blood Cell And Plasma, Therapeutic, a Unclassified device.