510(k) Report

FDA applicant

Joykey Industryial, Ltd.

Flagstaff, AZ2 decisions2007–20070 recalls

FDA records 2 decisions for Joykey Industryial, Ltd. (Flagstaff, AZ) in 2007: 2 510(k) clearances. Most are in product codes KKX (Drape, Surgical, Antimicrobial) and FYA (Gown, Surgical). Its devices cite 2 predicates, 0 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 and plastic surgery panel, where it files most

How often FDA has decided Joykey Industryial, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Joykey Industryial, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report