FDA applicant

Zerowet Splashield

Redondo Beach, CA1 decision1990–19900 recalls

FDA records 1 decision for Zerowet Splashield (Redondo Beach, CA) in 1990: 1 510(k) clearance. All are in product code KYZ (Syringe, Irrigating (Non Dental)). 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 Zerowet Splashield’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Zerowet Splashield since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Zerowet Splashield’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 “Zerowet”

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

Zerowet, Inc. 1

Zerowet Splashield

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Zerowet”