510(k) Report

FDA applicant

Alpha Therapeutic Corp.

Mchenry, IL8 decisions1981–19970 recalls

FDA records 8 decisions for Alpha Therapeutic Corp. (Mchenry, IL) from 1981 to 1997: 8 510(k) clearances. Most are in product codes CAK (Microfilter, Blood Transfusion) and KSB (Set, Transfer (Blood/Plasma)). Its devices cite 2 predicates, 2 of them its own earlier devices. 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Alpha Therapeutic Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Alpha Therapeutic Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Alpha”

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