510(k) Report

FDA applicant

Travenol Laboratories, S.A.

Mchenry, IL206 decisions1976–198844 recalls

FDA records 206 decisions for Travenol Laboratories, S.A. (Mchenry, IL) from 1976 to 1988: 206 510(k) clearances. Most are in product codes FRN (Pump, Infusion) and FPA (Set, Administration, Intravascular). 44 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, general hospital panel, where it files most

How often FDA has decided Travenol Laboratories, S.A.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Travenol Laboratories, S.A. since 2007.

Recalls per year

3in 2015

2010: 12011: 32013: 22015: 3
2007high 3 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Travenol”

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