510(k) Report

FDA applicant

Evoqua Water Technologies, LLC

Lowell, MA2 decisions2016–20230 recalls

FDA records 2 decisions for Evoqua Water Technologies, LLC (Lowell, MA) from 2016 to 2023: 2 510(k) clearances. Most are in product codes NHV (System, Water Purification, General Medical Use) and FIP (Subsystem, Water Purification). Its devices cite 3 predicates, 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 Evoqua Water Technologies, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2016: 12023: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Evoqua Water Technologies, LLC by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Evoqua Water Technologies, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NHVSystem, Water Purification, General Medical Use1decision
  • FIPSubsystem, Water Purification1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K153784Nosogard FiltersEvoqua Water Technologies, LLC · 20162cite it

What has FDA decided for it lately?

  • K231410RenaPure Endotoxin Retentive FilterEvoqua Water Technologies, LLC · 2023
  • K153784Nosogard FiltersEvoqua Water Technologies, LLC · 2016

All 2 as Evoqua Water Technologies, LLC →