FDA applicant

Gambro Bct, Inc.

Lakewood2 decisions1982–20074 recalls

FDA records 2 decisions for Gambro Bct, Inc. (Lakewood) from 1982 to 2007: 1 510(k) clearance and 1 original PMA approval. 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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

2in 2011

2007high 2 (2011) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Gambro Bct, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Gambro Bct, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Gambro”

FDA records each applicant name separately; these may or may not be the same firm.

Gambro, Inc. 87 Gambro Renal Products 37 Gambro Healthcare 13 Gambro-Hospal, Inc. 3 Gambro Renal Care Products 2 Gambro Services, Inc. 1 Gambro-Hosp-Cobe, Inc. 1

Gambro Bct, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Gambro”