510(k) Report

FDA applicant

Richard James, Inc.

Lynnfield, MA2 decisions1988–19900 recalls

FDA records 2 decisions for Richard James, Inc. (Lynnfield, MA) from 1988 to 1990: 2 510(k) clearances. Most are in product codes HPN (Magnet, Permanent) and FRN (Pump, Infusion). 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, ophthalmic panel, where it files most

How often FDA has decided Richard James, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Richard James, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Richard”

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