FDA applicant

Aqua Ark, Inc.

Allentown, PA1 decision1986–19860 recalls

FDA records 1 decision for Aqua Ark, Inc. (Allentown, PA) in 1986: 1 510(k) clearance. All are in product code ILJ (Bath, Hydro-Massage). 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 Aqua Ark, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Aqua Ark, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Aqua Ark, Inc.’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 “Aqua”

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

Aqua Medical, Inc. 5 Aqua-Med Systems, Inc. 1 Aqua Water Treatment, Inc. 1 Aqua Care Corp. 1 Aqua-Tools 1 Aqua Massage Intl., Inc. 1 Aqua Sciences, Inc. 1 Aqua-Air Medical Devices, Inc. 1

Aqua Ark, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Aqua”