510(k) Report

510(k) · Cleared

Cleared

Wro 300 Water Purification System for Hemodialysis

K042797510(k) AbbreviatedCleared Mar 9, 2005152-day reviewClass II21 CFR 876.5665

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

Gambro Renal Products · FIP Subsystem, Water Purification

Cleared on Mar 9, 2005 as substantially equivalent to K811678 (Gambro, Inc., 1981) after a 152-day review. Its family tree reaches back 1 generation to 1981. 14 later devices descend from it.

Decided
Mar 9, 2005
Review
152 days
Class
Class II
Product code
FIP
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K811678 (1981). 14 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2013: 1 descendant cleared2020: 1 descendant cleared2019: 1 descendant cleared2015: 1 descendant cleared2011: 1 descendant cleared2014: 2 descendants cleared2018: 1 descendant cleared2023: 1 descendant cleared2025: 2 descendants cleared2024: 1 descendant cleared2022: 1 descendant clearedK811678 · Gambro Water Purification Monitor WRD · Gambro, Inc. · 198119801990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 5 descendants3 generations forward: 5 descendants4 generations forward: 2 descendants5 generations forward: 1 descendant K811678 · Gambro Water Purification Monitor WRD · Gambro, Inc. · 19810+5
  1. Root · 1 generation backK811678 Gambro Water Purification Monitor WRDGambro, Inc. · 1981
  2. This deviceK042797 Wro 300 Water Purification System for HemodialysisGambro Renal Products · 2005
  3. Descendant · cites it directly · 13 of its ownK093608 Gambro Water Purification Unit, Models Wro 300 and Wro 300 HGambro Renal Products, Inc. · 2010
  4. Descendant · 2 generations on · 6 of its ownK110578 Millenium HX Portable Reverse Osmosis Water Purification SystemMar Cor Purification, Inc. · 2011 · Recalled
  5. Descendant · 2 generations on · 5 of its ownK124059 Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT)Lauer Membran Wassertechnik GmbH · 2013
  6. Descendant · 3 generations on · 3 of its ownK133829 Aquabplus,Aquabplus & Aquabplus B2,Aquabplus&Aquabplus HF,Aquabplus&…Vivonic GmbH · 2014 · Recalled
  7. Descendant · 4 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

2010: 12011: 12013: 12014: 22015: 12018: 12019: 12020: 12022: 12023: 12024: 12025: 2
2010high 2 (2014) · low 0 (2012)2026

Most influential descendants

Showing 5 of 14 · See all
  • K093608Gambro Water Purification Unit, Models Wro 300 and Wro 300 HGambro Renal Products, Inc. · 2010 · cites it directly13descendants
  • K110578Millenium HX Portable Reverse Osmosis Water Purification SystemMar Cor Purification, Inc. · 2011 · 2 generations on6descendants
  • K124059Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT)Lauer Membran Wassertechnik GmbH · 2013 · 2 generations on5descendants
  • K133829Aquabplus,Aquabplus & Aquabplus B2,Aquabplus&Aquabplus HF,Aquabplus& Aquabplus B2&…Vivonic GmbH · 2014 · 3 generations on3descendants
  • K213507AquaAFresenius Medical Care Rental Therapies Group, LLC · 2022 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K811678Gambro Water Purification Monitor WRDGambro, Inc.1981—
0 (this device)K042797Wro 300 Water Purification System for HemodialysisGambro Renal Products2005—
+1K093608Gambro Water Purification Unit, Models Wro 300 and Wro 300 HGambro Renal Products, Inc.2010—
+2K110578Millenium HX Portable Reverse Osmosis Water Purification SystemMar Cor Purification, Inc.20111
+2K124059Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT)Lauer Membran Wassertechnik GmbH2013—
+3K133829Aquabplus,Aquabplus & Aquabplus B2,Aquabplus&Aquabplus HF,Aquabplus& Aquabplus…Vivonic GmbH20143
+4K213507AquaAFresenius Medical Care Rental Therapies Group, LLC2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
201310
201420
201510
201810
201910
202010
202210
202310
202410
202520
FIG. 1 — Lineage of K042797, 1981–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K811678Gambro Water Purification Monitor WRD
Summary page 1
…76.5665 C. Predicate Device Information Predicate Device Name: Gambro WRO 10-01 FDA Clearance: K811678 Page 1 of 2…
Gambro, Inc.1981—

Also cleared against K811678: 1 other device →

What descends from it? (14)

See all 14

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K093608Gambro Water Purification Unit, Models Wro 300 and Wro 300 HGambro Renal Products, Inc.201013

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K093608 (Gambro Renal Products, Inc., 2010) has gone furthest, with 13 descendants of its own.
  • 1 other device also cites its predicate K811678.

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 WRO 300 Water Purification System is intended to be used as a dialysis accessory device in conjunction with one dialysis machine to produce water used to prepare and dilute dialysis concentrate to form dialysis fluid by using the reverse osmosis concept.

Indications for use as stated in the FDA summary.

Also cleared against K811678

1 other device cites the same predicate.

  • K010131PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard Plumbing Kit-1W604…Aksys, Ltd. · 20021 recall

More from Gambro Renal Products

24 FDA decisions under this applicant name. See the company

  • K120333Prismasate Dialysis Solutions for Continuius Renal Replacement TherapyGambro Renal Products · 2012
  • K072908Prismasate Dialysis Solutions for Continuous Renal Replacement TherapyGambro Renal Products · 20081 recall
  • K070414Gambro Cartridge Blood SetsGambro Renal Products · 200712 recalls
  • K063290Gambro Quickset BloodlinesGambro Renal Products · 2007
  • K062090Prisma System R03.10AGambro Renal Products · 2006

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/K042797 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042797: Wro 300 Water Purification System for Hemodialysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042797

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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