510(k) Report

FDA applicant

Sterling Medivations, Inc.

Wayzata, MN27 decisions2000–20020 recalls

FDA records 27 decisions for Sterling Medivations, Inc. (Wayzata, MN) from 2000 to 2002: 27 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FMI (Needle, Hypodermic, Single Lumen). Its devices cite 15 predicates, 12 of them its own earlier devices. 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 Sterling Medivations, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sterling Medivations, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sterling Medivations, 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 “Sterling”

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