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Pure Water, Inc.'s Bicarb Mix, Storage and Distribution System

by Pure Water, Inc.

510(k) K993272

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK993272 Date10 Apr 2000ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0033-2012 FDA Unclassified (pre-2012) initiated 19 May 2011 on shared 510(k) K993272

    Software problem causes transfer line between mixing and storage tank to not be rinsed after disinfection, leaving residual chlorine in the line.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FIN
Device Class
Class II
Regulation
21 CFR Part 876.5820
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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