510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Gambro Central Water Treatment System CWP 100 - Wro H

K974899510(k) TraditionalCleared Sep 23, 1998267-day reviewClass II21 CFR 876.5665Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Gambro Healthcare · FIP Subsystem, Water Purification

Cleared on Sep 23, 1998 as substantially equivalent to K931595 (Osmonics, Inc., 1994) after a 267-day review. Its family tree reaches back 1 generation to 1994. 14 later devices descend from it. It has been recalled 2 times.

Decided
Sep 23, 1998
Review
267 days
Class
Class II
Product code
FIP
Recalls
2
Predicates
1

Its longest line of descent runs back 1 generation to K931595 (1994). 14 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2013: 2 descendants cleared2000: 1 descendant cleared2014: 4 descendants cleared2010: 1 descendant cleared2015: 1 descendant cleared2023: 2 descendants cleared2024: 1 descendant cleared2022: 1 descendant cleared2025: 1 descendant clearedK931595 · Reverse Osmosis Equipment for Water Purification · Osmonics, Inc. · 19941990200020102020
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 8 descendants3 generations forward: 1 descendant K931595 · Reverse Osmosis Equipment for Water Purification · Osmonics, Inc. · 19940
  1. Root · 1 generation backK931595 Reverse Osmosis Equipment for Water PurificationOsmonics, Inc. · 1994
  2. This deviceK974899 Gambro Central Water Treatment System CWP 100 - Wro HGambro Healthcare · 1998
  3. Descendant · cites it directly · 5 of its ownK124059 Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT)Lauer Membran Wassertechnik GmbH · 2013
  4. Descendant · cites it directly · 3 of its ownK133829 Aquabplus,Aquabplus & Aquabplus B2,Aquabplus&Aquabplus HF,Aquabplus&…Vivonic GmbH · 2014 · Recalled
  5. Descendant · cites it directly · 3 of its ownK093641 TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC · 2010 · Recalled
  6. Descendant · cites it directly · 2 of its ownK131904 Mediqa Single Pass Reverse Osmosis System with Heat Sanitization…Ameriwater · 2013
  7. Descendant · 2 generations on · 1 of its ownK213507 AquaAFresenius Medical Care Rental Therapies Group, LLC · 2022

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2000: 12010: 12013: 22014: 42015: 12022: 12023: 22024: 12025: 1
2000high 4 (2014) · low 0 (2001)2026

Most influential descendants

Showing 5 of 14 · See all
  • K124059Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT)Lauer Membran Wassertechnik GmbH · 2013 · cites it directly5descendants
  • K133829Aquabplus,Aquabplus & Aquabplus B2,Aquabplus&Aquabplus HF,Aquabplus& Aquabplus B2&…Vivonic GmbH · 2014 · cites it directly3descendants
  • K093641TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC · 2010 · cites it directly3descendants
  • K131904Mediqa Single Pass Reverse Osmosis System with Heat Sanitization, Mediqa Double Pass…Ameriwater · 2013 · cites it directly2descendants
  • K213507AquaAFresenius Medical Care Rental Therapies Group, LLC · 2022 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K931595Reverse Osmosis Equipment for Water PurificationOsmonics, Inc.1994—
0 (this device)K974899Gambro Central Water Treatment System CWP 100 - Wro HGambro Healthcare1998—
+1K124059Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT)Lauer Membran Wassertechnik GmbH2013—
+1K133829Aquabplus,Aquabplus & Aquabplus B2,Aquabplus&Aquabplus HF,Aquabplus& Aquabplus…Vivonic GmbH20143
+1K093641TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC20101
+1K131904Mediqa Single Pass Reverse Osmosis System with Heat Sanitization, Mediqa…Ameriwater2013—
+2K213507AquaAFresenius Medical Care Rental Therapies Group, LLC2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
201010
201320
201440
201510
202210
202320
202410
202510
FIG. 1 — Lineage of K974899, 1994–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FIP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FIP device

  1. #1 K251851 DIASAFEplusUS (F00013010)score 14.1 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K931595Reverse Osmosis Equipment for Water Purification
Summary page 4
…n systems for hemodialysis in commercial distribution in the United States to include the Osmonics Osmo 23 G Series Reverse Osmosis Machines (FDA Document Control Number K931595 B. Both systems utilized reverse osmosis for purification of water to be used for hemodialysis. Both systems utilize a polyamide,…
Osmonics, Inc.1994—

Also cleared against K931595: 2 other devices →

What descends from it? (14)

See all 14

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K124059Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT)Lauer Membran Wassertechnik GmbH20135
K133829Aquabplus,Aquabplus & Aquabplus B2,Aquabplus&Aquabplus HF,Aquabplus& Aquabplus B2&…Vivonic GmbH20143
K093641TANGO3 Water Storage Tank with Ozone Disinfection SystemTango3, LLC20103
K131904Mediqa Single Pass Reverse Osmosis System with Heat Sanitization, Mediqa Double Pass…Ameriwater20132
K991916Virginia Water Systems' Water Purification System for HemodialysisVirginia Water Systems, Inc.20000

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 24, 2014Class IIZ-1563-2014Nonconforming Material/ComponentMar Cor Purification manufactured Central Water Plant (CWP) reverse osmosis system, models 102, 104 and 106. This correction has been initiated due to a potential situation with a specific lot of the water inlet solenoid valve. The…
Jun 27, 2012Class IIZ-1201-2014Component design/selectionThere exists a potential situation with the crimp connection at the pump head assembly. The potential exists that the reverse osmosis pump head wiring could build resistance resulting in resistive heating of the surrounding components. If…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K124059 (Lauer Membran Wassertechnik GmbH, 2013) has gone furthest, with 5 descendants of its own.
  • 2 other devices also cite its predicate K931595.

How does its category compare?

All FIP devices

FIP Subsystem, Water Purification: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FIP

4in 2025

2007: 12008: 32009: 32010: 22011: 42012: 22013: 42014: 42015: 22016: 22017: 12018: 12019: 22020: 12021: 12022: 12023: 32024: 12025: 4
2007high 4 (2011) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FIP

88in 2025

2008: 202 days median2009: 167 days median2011: 116 days median2013: 125 days median2014: 126 days median2023: 69 days median2025: 88 days median
2007high 202 (2008) · low 69 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FIP

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FIP

77in 2025

2007: 12008: 52010: 122011: 42012: 42013: 412014: 342015: 122016: 32017: 62018: 32019: 132020: 122021: 352022: 572023: 1402024: 1742025: 77
2007high 174 (2024) · low 0 (2009)2025

MAUDE reports naming product code FIP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—01
2008320205
2009316700
20102—012
2011411604
20122—04
20134125041
20144126034
20152—012
20162—03
20171—06
20181—03
20192—013
20201—112
20211—035
20221—057
20233690140
20241—0174
2025488077
20260—0—

What is it indicated for?

The Gambro Central Water Treatment System CWP 100 — WRO H is designed to produce water of adquate quality for hemodialysis, both chemically and microbiologically with an adequate flow, provided that the feed water complies with the existing standards for drinking water and has been properly pre-treated.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K931595

2 other devices cite the same predicate.

  • K993520H20NLY Complete Water Purification System for HemodialysisServ-A-Pure Co. · 2000
  • K991916Virginia Water Systems' Water Purification System for HemodialysisVirginia Water Systems, Inc. · 2000

More from Gambro Healthcare

13 FDA decisions under this applicant name. See the company

  • K994390Gambro Polyflux 17R, Capillary Dialyzer/ FilterGambro Healthcare · 2000
  • K990039Gambro DQM 200Gambro Healthcare · 2000
  • K982413Cobe Arylane H1, H4, H6 & H9 Hemodialyzers/FiltersGambro Healthcare · 1999
  • K982414Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ HemofiltersGambro Healthcare · 1999
  • K980386Hospal Multiflow 100, Multiflow 100 Kits A0 (A0,A0/B and A0/0), Multiflow 100 Kits B22 (B22,B22/B, & B22/0)Gambro Healthcare · 19991 recall

Recent decisions in FIP

The FIP category page

  • K250471AquaC UNO HFresenius Medical Care Renal Therapies Group, LLC · 2025
  • K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC · 2025
  • K252181AquaAFresenius Medical Care North America · 2025
  • K250514UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc. · 2025
  • K232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLC · 2024

https://510kreport.com/device/K974899 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974899: Gambro Central Water Treatment System CWP 100 - Wro H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974899

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026