510(k) Report

FDA applicant

Emde Corp.

Mchenry, IL4 decisions1977–19860 recalls

FDA records 4 decisions for Emde Corp. (Mchenry, IL) from 1977 to 1986: 4 510(k) clearances. Most are in product codes CBT (Arterial Blood Sampling Kit) and KNT (Tubes, Gastrointestinal (And Accessories)). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Emde Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Emde Corp.’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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