FDA applicant

Genesis Labs, Inc.

Edina, MN3 decisions1994–19960 recalls

FDA records 3 decisions for Genesis Labs, Inc. (Edina, MN) from 1994 to 1996: 3 510(k) clearances. Most are in product codes JIL (Method, Enzymatic, Glucose (Urinary…) and JJB (Azo-Dyes, Colorimetric, Bilirubin & Its…). Its devices cite 2 predicates, 1 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, clinical chemistry panel, where it files most

How often FDA has decided Genesis Labs, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Genesis Labs, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Genesis Labs, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Genesis”

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

Genesis Industries, Inc. 17 Genesis Fracture Care, Inc. 5 Genesis Biosystems, Inc. 4 Genesis Orthopedics, Inc. 2 Genesis Digital Imaging, Inc. 2 Genesis Software Innovations 2 Genesis Medical, Inc. 2 Genesis Medical Interventional, Inc. 2 Genesis Medical Technology, Inc. 1 Genesis Health Technologies 1 Genesis Air, Inc. 1 Genesis Health Light Corporation 1

Genesis Labs, 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?

Other applicant names beginning “Genesis”