FDA applicant

Ortho Instruments

Mchenry, IL6 decisions1978–19800 recalls

FDA records 6 decisions for Ortho Instruments (Mchenry, IL) from 1978 to 1980: 6 510(k) clearances. Most are in product codes GKL (Counter, Cell, Automated (Particle Counter)) and JPK (Mixture, Hematology Quality Control). 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, hematology panel, where it files most

How often FDA has decided Ortho Instruments’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ortho Instruments since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Ortho”

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

Ortho-Clinical Diagnostics, Inc. 152 Ortho Diagnostic Systems, Inc. 126 Ortho Development Corp. 64 Ortho Diagnostics, Inc. 24 Ortho Tec, LLC 22 Ortho Pharmaceutical Corp. 9 Ortho Source 9 Ortho Organizers, Inc. 8 Ortho Kinetics Corp. 7 Ortho Solutions Limited 6 Ortho Kinematics, Inc. 6 Ortho Solutions UK, Ltd. 5

Ortho Instruments

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Ortho”