510(k) Report

FDA applicant

Caridianbct, Inc..

Lakewood, CO2 decisions2010–20124 recalls

FDA records 2 decisions for Caridianbct, Inc.. (Lakewood, CO) from 2010 to 2012: 2 510(k) clearances. All are in product code LKN (Separator, Automated, Blood Cell And Plasma…). 4 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Caridianbct, Inc..’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2010: 12012: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2012

2010: 12011: 22012: 1
2010high 2 (2011) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Caridianbct, Inc.. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LKNSeparator, Automated, Blood Cell And Plasma, Therapeutic2decisions

What has FDA decided for it lately?

  • K113480Spectra Optia Apheresis SystemCaridianbct, Inc.. · 2012
  • K103090Spectra Optia R Apheresis SystemCaridianbct, Inc.. · 20104 recalls

All 2 as Caridianbct, Inc.. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K103090Terumo BCT Lakewood, CO 80215, Catalog No 61000 Spectra Optia Apheresis System, Country…May 4, 2012
  • K071079Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000.Oct 26, 2011
  • K071079Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. A blood…Sep 21, 2011
  • K071079Spectra Optia Apheresis System, REF: 61000, CaridianBCT, Lakewood, CO 80215. The Spectra…Dec 9, 2010