FDA applicant

Biotek-Caribbean

Santo Domingo, Dom. Rep., DO1 decision1985–19850 recalls

FDA records 1 decision for Biotek-Caribbean (Santo Domingo, Dom. Rep., DO) in 1985: 1 510(k) clearance. All are in product code CBT (Arterial Blood Sampling Kit). No recall is linked to its devices.

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

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Biotek-Caribbean’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biotek-Caribbean since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Biotek-Caribbean”

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

Biotek Solutions, Inc. 6

Biotek-Caribbean

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Biotek-Caribbean”