Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FIP · Predicate Candidate Screening
117 FDA 510(k) clearances under this product code; the 50 most recent screened below.
187 daysmedian FDA review time
429 days90th percentile
117clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250471 | AquaC UNO H | Fresenius Medical Care Renal Therapies Group, LLC | 2025-11-14 | 269 | 0 |
| K251851 | DIASAFEplusUS (F00013010) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-10-09 | 115 | 0 |
| K252181 | AquaA | Fresenius Medical Care North America | 2025-09-09 | 60 | 0 |
| K250514 | UPT Series Medical RO Water Treatment System | Specialty Water Technologies, Inc. | 2025-03-17 | 24 | 0 |
| K232953 | AquaBplus; AquaB LITE | Fresenius Medical Care Renal Therapies Group, LLC | 2024-06-13 | 266 | 0 |
| K223479 | AQUAbase nX | B.Braun Medical, Inc. | 2023-08-16 | 271 | 0 |
| K231410 | RenaPure Endotoxin Retentive Filter | Evoqua Water Technologies, LLC | 2023-07-19 | 65 | 0 |
| K223656 | AmeriWater MediQA Reverse Osmosis System (MSP3HF) | AmeriWater, LLC | 2023-02-13 | 69 | 0 |
| K213507 | AquaA | Fresenius Medical Care Rental Therapies Group, LLC | 2022-07-27 | 268 | 0 |
| K211035 | U9000 Plus Ultrafilter | Baxter Healthcare Corporation | 2021-10-19 | 195 | 0 |
| K200670 | EON Portable RO Water Purification System | Mar Cor Purification, Inc. | 2020-04-16 | 34 | 0 |
| K192398 | Millenium HX | Mar Cor Purification, Inc. | 2019-10-03 | 30 | 0 |
| K182367 | DIASAFEplusUS | Fresenius Medical Care Renal Therapies Group, LLC | 2019-01-10 | 132 | 0 |
| K171099 | EON Portable Reverse Osmosis Water Purification System | Cantel | 2018-01-05 | 267 | 0 |
| K161304 | EndoPur Filter | Nephros, Inc. | 2017-03-02 | 296 | 0 |
| K161844 | Matrix Pre-Treatment Controller | Better Water, LLC | 2016-12-13 | 161 | 0 |
| K153329 | MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dia | Med-Tech Water Systems, Inc. | 2016-08-04 | 259 | 0 |
| K143617 | AquaC UNO H | Vivonic GmbH | 2015-10-19 | 304 | 5 |
| K151637 | UPT Series Medical RO Water System | Specialty Water Technologies | 2015-09-23 | 98 | 0 |
| K142285 | AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, | Ameriwater | 2014-12-01 | 105 | 0 |
| K133149 | BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM | Mar Cor Purification, Inc. | 2014-04-30 | 195 | 0 |
| K133829 | AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQ | Vivonic GmbH | 2014-04-22 | 126 | 0 |
| K133783 | AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT | Ameriwater | 2014-04-16 | 125 | 0 |
| K131904 | MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZA | Ameriwater | 2013-11-13 | 141 | 0 |
| K131622 | MROZ REVERSE OSMOSIS SYSTEM | Ameriwater | 2013-09-20 | 109 | 0 |
| K123282 | DEONIZATION EXCHANGE TANKS, CARBON EXCHANGE TANKS | Ultrapure & Industrial Services, LLC | 2013-04-25 | 185 | 0 |
| K124059 | AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT) | Lauer Membran Wassertechnik GmbH | 2013-03-25 | 84 | 0 |
| K121022 | AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & | Ameriwater | 2012-09-17 | 166 | 0 |
| K112331 | BIOPURE PORTABLE RO SYSTEMS | Arion Water, Inc. | 2012-07-05 | 328 | 0 |
| K111740 | AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATI | Ameriwater | 2011-10-05 | 106 | 1 |
| K110285 | NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER | Nephros, Inc. | 2011-07-14 | 164 | 0 |
| K110578 | MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYS | Mar Cor Purification, Inc. | 2011-05-20 | 80 | 1 |
| K102892 | ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS | Aqua Sciences, Inc. | 2011-02-03 | 126 | 0 |
| K093608 | GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H | Gambro Renal Products, Inc. | 2010-07-29 | 251 | 0 |
| K092481 | HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, M | New Aqua, LLC (Dba Aqua Systems) | 2010-04-02 | 232 | 0 |
| K083712 | WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS | Dipure, LLC | 2009-07-10 | 207 | 0 |
| K090885 | NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER | Nephros, Inc. | 2009-06-29 | 90 | 0 |
| K082400 | DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS | Culligan Soft Water Service Co. | 2009-02-03 | 167 | 0 |
| K080703 | BTI FILTRATION DEIONIZATION EXCHANGE TANK; BTI FILTRATION CA | 4m Ventures, Inc. | 2008-06-02 | 82 | 0 |
| K072158 | AQUA PURE DEIONIZER EXCHANGE SERVICE | Staubach Barror Water Systems, Inc. | 2008-02-21 | 202 | 0 |
| K071104 | ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL | Flier'S Quality Water Systems, Inc. | 2008-01-14 | 270 | 0 |
| K061782 | GAMBRO POSICLEAR | Gambro Services, Inc. | 2007-01-04 | 192 | 0 |
| K060942 | WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS | Bob J. Johnson & Associates | 2006-07-07 | 92 | 0 |
| K051620 | MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL | Better Water, Inc. | 2005-11-18 | 154 | 0 |
| K042018 | ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL | Simply Clean Air & Water, Inc. | 2005-04-15 | 262 | 0 |
| K043344 | DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM | Dialysis Services, Inc. | 2005-03-23 | 107 | 0 |
| K042797 | WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS | Gambro Renal Products | 2005-03-09 | 152 | 0 |
| K041884 | MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEM | Mueller Water Conditioning, Inc. | 2005-02-28 | 231 | 0 |
| K042089 | NX STAGE WATER PURIFICATION SYSTEM | Nxstage Medical, Inc. | 2004-11-24 | 113 | 0 |
| K031832 | MEGA PURE CART | Mega Services | 2004-10-20 | 495 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda