510(k) Report

FDA applicant

Sontek Corp.

Mchenry, IL3 decisions1981–19830 recalls

FDA records 3 decisions for Sontek Corp. (Mchenry, IL) from 1981 to 1983: 3 510(k) clearances. All are in product code DQO (Catheter, Intravascular, Diagnostic). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Sontek Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sontek 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 “Sontek”

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