510(k) Report

FDA applicant

Starcap Medical, LLC ( Dba Prism Medical & Design)

Parkland, FL1 decision2016–20160 recalls

FDA records 1 decision for Starcap Medical, LLC ( Dba Prism Medical & Design) (Parkland, FL) in 2016: 1 510(k) clearance. All are in product code FMI (Needle, Hypodermic, Single Lumen). 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 Starcap Medical, LLC ( Dba Prism Medical & Design)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Starcap Medical, LLC ( Dba Prism Medical & Design) by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Starcap Medical, LLC ( Dba Prism…’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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