# Terumobct, Inc.

- Location (FDA's records): Lakewood, CO
- FDA decisions: 8 (2013–2019): 8 510(k) clearances
- Product codes: LKN (7), KCY (1)
- Predicates its devices cite: 9 (3 its own); citations of its devices by later devices: 5 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Gambro Bct, Inc.: 2 (https://510kreport.com/company/gambro-bct)
- Intl. Business Machines: 2 (https://510kreport.com/company/intl-business-machines)
- Dominion Medical Devices, LLC: 1 (https://510kreport.com/company/dominion-medical-devices)
- Terumo Bct: 1 (https://510kreport.com/company/terumo-bct)

## Firms that cite its devices most
- Fresenius Kabi USA,Llc: 1 (https://510kreport.com/company/fresenius-kabi-usa)
- Terumo Bct: 1 (https://510kreport.com/company/terumo-bct)

## Its most-cited devices
- K132429: Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Exchange Disposable Set (2013), cited by 2
- K172590: Spectra Optia Apheresis System (2018), cited by 2
- K141938: Spectra Optia Apheresis System, Spectra Optia Exchange Set (Disposable Blood Tubing Set) (2015), cited by 1

## Recent decisions
- K183081: Spectra Optia Apheresis System (Feb 5, 2019)
- K181049: Spectra Optia Apheresis System (Nov 1, 2018)
- K172590: Spectra Optia Apheresis System (Mar 2, 2018)
- K162365: T-Cuff (Feb 16, 2017)
- K153601: Spectra Optia Apheresis System (Jan 14, 2016)
- K141938: Spectra Optia Apheresis System, Spectra Optia Exchange Set (Disposable Blood Tubing Set) (Mar 23, 2015)
- K132429: Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Exchange Disposable Set (Dec 6, 2013)
- K131744: Spectra Optia Apheresis System, Spectra Optia Single-Needle Connector, Spectra Optia System Software (Aug 8, 2013)

Source page: https://510kreport.com/company/terumobct