FDA applicant

Better Water, Inc.

Smyrna, TN5 decisions1995–20160 recalls

FDA records 5 decisions for Better Water, Inc. (Smyrna, TN) from 1995 to 2016: 5 510(k) clearances. Most are in product codes FIP (Subsystem, Water Purification) and FIN (Tank, Holding, Dialysis). Its devices cite 7 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Better Water, 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 Better Water, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2007high 1 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Other applicant names beginning “Better”

FDA records each applicant name separately; these may or may not be the same firm.

Better Care Plastic Technology Co., Ltd. 11 Better Hearing, Inc. 2 Better Care Plastic Technology Cp., Ltd. 2 Better Diagnostics AI Corp. 2 Better Health Medical Products Co., Ltd. 1 Better Life Medical Technologies, Inc. 1 Better Therapeutics 1 Better Care S.L. 1 Better Plastic Co., Ltd. 1

Better Water, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Better”