510(k) Report

FDA applicant

Ameriwater

Dayton, OH12 decisions2000–20231 recall

FDA records 12 decisions for Ameriwater (Dayton, OH) from 2000 to 2023: 12 510(k) clearances. Most are in product codes FIP (Subsystem, Water Purification) and FIN (Tank, Holding, Dialysis). Its devices cite 17 predicates, 7 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “AmeriWater, LLC”.

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 Ameriwater’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2011: 12012: 12013: 22014: 32023: 1
2007high 3 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Ameriwater’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?

  • FIPSubsystem, Water Purification10decisions
  • FINTank, Holding, Dialysis2decisions

Whose devices does it build on?

Its devices cite 17 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 7 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.

  • K991519Ameriwater Purification System for HemodialysisAmeriwater · 200010cite it
  • K111740Ameriwater Mro Portable Reverse Osmosis System - Single Patient, 1 to 3 StationAmeriwater · 20112cite it
  • K131904Mediqa Single Pass Reverse Osmosis System with Heat Sanitization, Mediqa Double Pass Reverse Osmosis System…Ameriwater · 20132cite it
  • K030059Portable RO+ Model MROS09Ameriwater · 20031cites it

What has FDA decided for it lately?

  • K223656AmeriWater MediQA Reverse Osmosis System (MSP3HF)AmeriWater, LLC · 2023
  • K141213Ameriwater Ozone Disinfection SystemAmeriwater · 2014
  • K142285AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan…Ameriwater · 2014
  • K133783Ameriwater Centurion 1500+ Reverse Osmosis System with Heat SanitizationAmeriwater · 2014
  • K131904Mediqa Single Pass Reverse Osmosis System with Heat Sanitization, Mediqa Double Pass Reverse Osmosis System…Ameriwater · 2013
  • K131622Mroz Reverse Osmosis SystemAmeriwater · 2013
  • K121022Ameriwater Alarm Panel - Base Model and Remote, Base Model & Remote with Conductivity, Base Model & Remote…Ameriwater · 2012
  • K111740Ameriwater Mro Portable Reverse Osmosis System - Single Patient, 1 to 3 StationAmeriwater · 20111 recall

All 11 as Ameriwater →The one decision as AmeriWater, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K111740AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404…Aug 9, 2012Class II