510(k) Report

FDA applicant

Kacey, Inc.

Rock Hill, SC1 decision2003–20030 recalls

FDA records 1 decision for Kacey, Inc. (Rock Hill, SC) in 2003: 1 510(k) clearance. All are in product code FMF (Syringe, Piston). 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 Kacey, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kacey, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Kacey, 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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