Better Water, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Better Water, Inc.” (first 1995, latest 2016), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 154 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 161 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FIP | Subsystem, Water Purification | 4 | 4 |
| FIN | Tank, Holding, Dialysis | 1 | 1 |
Review panels
Most recent Better Water, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161844 | Matrix Pre-Treatment Controller | FIP | 2016-12-13 | 161 |
| K051620 | MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES | FIP | 2005-11-18 | 154 |
| K992793 | SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM | FIN | 1999-11-16 | 89 |
| K954928 | PORTABLE REVERSE OSMOSIS MACHINE | FIP | 1996-01-24 | 90 |
| K920186 | WATER PURIFICATION SYSTEM FOR HEMODIALYSIS | FIP | 1995-06-13 | 1246 |
Recalls
openFDA lists no recalls under a recalling firm named Better Water, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Better Care Plastic Technology Co., Ltd. (11 510(k)s)
- Better Care Plastic Technology Cp., Ltd. (2 510(k)s)
- Better Diagnostics AI Corp. (2 510(k)s)
- Better Hearing, Inc. (2 510(k)s)
- Better Care S.L. (1 510(k)s)
- Better Health Medical Products Co., Ltd. (1 510(k)s)
- Better Life Medical Technologies, Inc. (1 510(k)s)
- Better Plastic Co., Ltd. (1 510(k)s)
- Better Therapeutics (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Better Water, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Better Water, Inc.” (first 1995, latest 2016), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Better Water, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Better Water, Inc. is 154 days.
Which FDA product codes appear under Better Water, Inc.?
The most frequent FDA product codes under this applicant name are FIP (Subsystem, Water Purification, 4); FIN (Tank, Holding, Dialysis, 1).
Next steps
- See all 5 Better Water, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FIP, Better Water, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.