FDA applicant

Organon, Inc.

Mchenry, IL42 decisions1977–20260 recalls

FDA records 42 decisions for Organon, Inc. (Mchenry, IL) from 1977 to 2026: 42 510(k) clearances. Most are in product codes JHJ (Agglutination Method, Human Chorionic…) and JHI (Visual, Pregnancy Hcg, Prescription Use). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Organon, LLC”.

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 Organon, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2007high 1 (2026) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Organon, 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 “Organon”

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

Organon Teknika Corp. 134 Organon Teknika Treyburn 1

Organon, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Organon”