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510(k) K182164

Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand by Ecolab, Inc. — Product Code NHV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2019
Date Received
August 10, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Water Purification, General Medical Use
Device Class
Class II
Regulation Number
876.5665
Review Panel
GU
Submission Type

The device is a portable water treatment system which features components and technology similar to water treatment systems previously cleared for hemodialysis. The difference lies with the intended use, as the proposed device is not intended for use in hemodialysis applications, for which a product code currently exists. Instead, the proposed device is intended for use to purify water for general purposes, including washing of surgeons hands, surgical instruments, and wound cleansing.

Other clearances by Ecolab, Inc.

  • K173164 — Ecolab POU Water Filter (June 29, 2018)
  • K152522 — ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes (January 15, 2016)
  • K150190 — IntraTemp Solution Warmer (February 26, 2015)
  • K142173 — NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE (December 30, 2014)
  • K142080 — NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE (August 28, 2014)
  • K883593 — #400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAY (September 30, 1988)

Other clearances for product code NHV

  • K222727 — i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) (June 2, 2023)
  • K191563 — FILTRAY 2G Disposable Water Filters (October 25, 2019)
  • K173164 — Ecolab POU Water Filter (June 29, 2018)
  • K163609 — Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Fau (June 1, 2017)
  • K161467 — HydraGuard 10 UltraFilter (December 22, 2016)
  • K153784 — NOSOGARD FILTERS (October 21, 2016)
  • K153434 — Pall-Aquasafe Water Filter (June 10, 2016)
  • K153084 — Nephros S100 (April 8, 2016)
  • K141731 — NEPHROS DSU-H, NEPHROS SSU-H (October 24, 2014)
  • K012716 — MAINSTREAM WATER PURIFICATION DEVICE (May 7, 2002)