510(k) Report

FDA applicant

Rd Medical Mfg., Inc.

Culebra, PR4 decisions1999–20010 recalls

FDA records 4 decisions for Rd Medical Mfg., Inc. (Culebra, PR) from 1999 to 2001: 4 510(k) clearances. 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 Rd Medical Mfg., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rd Medical Mfg., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Rd Medical Mfg., 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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