FDA applicant

White River Concepts

San Clemente, CA3 decisions1997–19970 recalls

FDA records 3 decisions for White River Concepts (San Clemente, CA) in 1997: 3 510(k) clearances. Most are in product codes HGX (Pump, Breast, Powered) and HGY (Pump, Breast, Non-Powered). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided White River Concepts’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for White River Concepts since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like White River Concepts’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 “White”

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

White Knight Healthcare 8 White Peaks Dental Systems GmbH & Co. KG 3 White River (Tm) 2 White-Rodgers, Div. Emerson Electric Co. 1

White River Concepts

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “White”