FDA applicant

Osborn Group, Inc.

Olathe, KS4 decisions1999–200037 recalls

FDA records 4 decisions for Osborn Group, Inc. (Olathe, KS) from 1999 to 2000: 4 510(k) clearances. Most are in product codes CGX (Alkaline Picrate, Colorimetry, Creatinine) and JKA (Tubes, Vials, Systems, Serum Separators, Blood…). Its devices cite 5 predicates, 0 of them its own earlier devices. 37 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Osborn Group, Inc. since 2007.

Recalls per year

37in 2011

2007high 37 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Osborn Group, 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 “Osborn”

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

Osborn Laboratories, Inc. 2 Osborn Medical Corp. 2

Osborn Group, 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 “Osborn”