FDA applicant

Soma Intl., Inc.

S. Plainfield, NJ1 decision1986–19860 recalls

FDA records 1 decision for Soma Intl., Inc. (S. Plainfield, NJ) in 1986: 1 510(k) clearance. All are in product code LHI (Set, I.V. Fluid Transfer). 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 Soma Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Soma Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Soma Intl., 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 “Soma”

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

Soma Blue, Inc. 2 Soma Access Systems, LLC 1 Soma International, Ltd. 1

Soma Intl., Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Soma”