510(k) Report

FDA applicant

New Aqua, LLC (Dba Aqua Systems)

Avon, IN1 decision2010–20100 recalls

FDA records 1 decision for New Aqua, LLC (Dba Aqua Systems) (Avon, IN) in 2010: 1 510(k) clearance. All are in product code FIP (Subsystem, Water Purification). Its devices cite 1 predicate, 0 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, gastroenterology and urology panel, where it files most

How often FDA has decided New Aqua, LLC (Dba Aqua Systems)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — New Aqua, LLC (Dba Aqua Systems) by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FIPSubsystem, Water Purification1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K092481Hemodialysis Carbon Exchange, Dual Bed Deionizer Exchange, Mixed Bed Deionizer Exchange, Model…New Aqua, LLC (Dba Aqua Systems) · 2010

The one decision as New Aqua, LLC (Dba Aqua Systems) →