510(k) Report

FDA applicant

Edlaw Pharmaceuticals, Inc.

Mchenry, IL3 decisions1981–19840 recalls

FDA records 3 decisions for Edlaw Pharmaceuticals, Inc. (Mchenry, IL) from 1981 to 1984: 3 510(k) clearances. Most are in product codes KPO (Dialysate Concentrate For Hemodialysis (Liquid…) and KOC (Accessories, Blood Circuit, Hemodialysis). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Edlaw Pharmaceuticals, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Edlaw Pharmaceuticals, 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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