Ameriwater: FDA clearances and approvals
Ameriwater has 12 FDA 510(k) clearances (first 2000, latest 2023), across 2 product codes in 1 review panel. Median 510(k) review time: 133 days. openFDA lists 2 product recalls by a recalling firm named Ameriwater.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 166 |
| 2013 | 2 | 125 |
| 2014 | 3 | 125 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 69 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Ameriwater's cleared 510(k)s took a median 69 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 132 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FIP | Subsystem, Water Purification | 10 | 10 |
| FIN | Tank, Holding, Dialysis | 2 | 2 |
Review panels
Most recent Ameriwater 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223656 | AmeriWater MediQA Reverse Osmosis System (MSP3HF) | FIP | 2023-02-13 | 69 |
| K141213 | AMERIWATER OZONE DISINFECTION SYSTEM | FIN | 2014-12-10 | 212 |
| K142285 | AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz | FIP | 2014-12-01 | 105 |
| K133783 | AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION | FIP | 2014-04-16 | 125 |
| K131904 | MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA | FIP | 2013-11-13 | 141 |
| K131622 | MROZ REVERSE OSMOSIS SYSTEM | FIP | 2013-09-20 | 109 |
| K121022 | AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV | FIP | 2012-09-17 | 166 |
| K111740 | AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION | FIP | 2011-10-05 | 106 |
| K051031 | AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS | FIN | 2006-01-06 | 259 |
| K021560 | MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS | FIP | 2003-08-14 | 458 |
2 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2012-08-09.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Ameriwater have?
Ameriwater has 12 FDA 510(k) clearances (first 2000, latest 2023), across 2 product codes in 1 review panel.
How long does FDA take to clear Ameriwater's 510(k)s?
The median time from FDA receipt to decision across Ameriwater's cleared 510(k)s is 133 days.
What devices does Ameriwater make?
Its most frequent FDA product codes are FIP (Subsystem, Water Purification, 10); FIN (Tank, Holding, Dialysis, 2).
Has Ameriwater had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Ameriwater; the most recent began 2012-08-09. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 12 Ameriwater clearances with predicates and recalls
- Run predicate analysis for product code FIP, Ameriwater's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.