510(k) Report

FDA applicant

Tamaryn Medical Systems, Inc.

Salt Lake City, UT1 decision1997–19970 recalls

FDA records 1 decision for Tamaryn Medical Systems, Inc. (Salt Lake City, UT) in 1997: 1 510(k) clearance. All are in product code FPA (Set, Administration, Intravascular). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Tamaryn Medical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • FPASet, Administration, Intravascular1decision

What has FDA decided for it lately?

  • K971066Tamaryn I.V. Flow Regulator Extension SetTamaryn Medical Systems, Inc. · 1997

The one decision as Tamaryn Medical Systems, Inc. →