FDA applicant

Deltec, Inc.

St. Paul, MN5 decisions2002–200310 recalls

FDA records 5 decisions for Deltec, Inc. (St. Paul, MN) from 2002 to 2003: 5 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and MSD (Catheter, Hemodialysis, Implanted). Its devices cite 4 predicates, 0 of them its own earlier devices. 10 recalls are linked to its devices, 1 Class I.

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

FIG. A — Illustration, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Deltec, Inc. since 2007.

Recalls per year

1in 2022

2007high 3 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Deltec”

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

Deltec Systems, Inc. 9

Deltec, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

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What has been recalled?

Other applicant names beginning “Deltec”