510(k) Report

FDA applicant

Alphamed, Inc.

El Paso, TX4 decisions1993–20190 recalls

FDA records 4 decisions for Alphamed, Inc. (El Paso, TX) from 1993 to 2019: 4 510(k) clearances. Most are in product codes FRW (Scale, Patient) and MNR (Ventilatory Effort Recorder). Its devices cite 3 predicates, 0 of them its own earlier devices. 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 Alphamed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2009: 12019: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Alphamed, 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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