510(k) Report

FDA applicant

Patient Solutions, Inc.

San Diego, CA5 decisions1989–19970 recalls

FDA records 5 decisions for Patient Solutions, Inc. (San Diego, CA) from 1989 to 1997: 5 510(k) clearances. Most are in product codes FRN (Pump, Infusion) and 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 Patient Solutions, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Patient Solutions, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Patient Solutions, 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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Other applicant names beginning “Patient”

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