FDA applicant

Zenith Technical Innovations

Gurnee, IL5 decisions2018–20240 recalls

FDA records 5 decisions for Zenith Technical Innovations (Gurnee, IL) from 2018 to 2024: 5 510(k) clearances. Most are in product codes IRP (Massager, Powered Inflatable Tube) and JOW (Sleeve, Limb, Compressible). Since 2016 its 510(k)s took a median of 70 days from receipt to decision, against 143 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 5 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, physical medicine panel, where it files most

How often FDA has decided Zenith Technical Innovations’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2018high 1 (2018) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Zenith Technical Innovations by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Zenith Technical Innovations’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 “Zenith”

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

Zenith Hearing Instrument Co. 1 Zenith/Omni Hearing Instruments, Inc. 1 Zenith-Omni H.C., Inc. 1

Zenith Technical Innovations

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Zenith”