FDA applicant

Sorenson Medical, Inc.

West Jordan, UT6 decisions1999–20055 recalls

FDA records 6 decisions for Sorenson Medical, Inc. (West Jordan, UT) from 1999 to 2005: 6 510(k) clearances. Most are in product codes FRN (Pump, Infusion) and KPE (Container, I.V.). Its devices cite 6 predicates, 4 of them its own earlier devices. 5 recalls are 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 Sorenson Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sorenson Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sorenson Medical, 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 “Sorenson”

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

Sorenson Laboratories, Inc. 3 Sorenson Critical Care 1

Sorenson Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Sorenson”