Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nxstage Medical, Inc. — Predicate Candidate Screening
51 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
108 daysmedian FDA review time
271 days90th percentile
51clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232803 | NxStage System One with Cartridge Express (CAR-170-E and CAR | Nxstage Medical, Inc. | 2024-03-14 | 184 | 0 |
| K233213 | NxStage PureFlow Solution | Nxstage Medical, Inc. | 2024-01-18 | 112 | 0 |
| K230632 | VersiHD with GuideMe software | Nxstage Medical, Inc. | 2023-08-11 | 157 | 0 |
| K183158 | NxStage Cartridge Express with Speedswap | Nxstage Medical, Inc. | 2019-08-09 | 267 | 1 |
| K181991 | NxStage Connected Health System | Nxstage Medical, Inc. | 2018-09-26 | 62 | 0 |
| K171331 | NxStage System One | Nxstage Medical, Inc. | 2017-08-24 | 108 | 0 |
| K170469 | NxStage System One Plus | Nxstage Medical, Inc. | 2017-05-09 | 82 | 0 |
| K150472 | NxStage System One | Nxstage Medical, Inc. | 2015-06-04 | 101 | 0 |
| K143313 | NxStage Therapeutic Plasma Exchange (TPE) Cartridge | Nxstage Medical, Inc. | 2015-03-20 | 121 | 0 |
| K141752 | NXSTAGE SYSTEM ONE | Nxstage Medical, Inc. | 2014-12-19 | 172 | 0 |
| K134019 | MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI- | Nxstage Medical, Inc. | 2014-09-11 | 255 | 0 |
| K140623 | NXSTAGE EXPRESS FLUID WARMER | Nxstage Medical, Inc. | 2014-06-16 | 97 | 0 |
| K140526 | NXSTAGE SYSTEM ONE | Nxstage Medical, Inc. | 2014-05-19 | 76 | 0 |
| K140571 | NXSTAGE PUREFLOW SL | Nxstage Medical, Inc. | 2014-05-15 | 70 | 8 |
| K133547 | NXSTAGE SYSTEM ONE WITH NXVIEW | Nxstage Medical, Inc. | 2014-03-03 | 104 | 0 |
| K132602 | STREAMLINE EXPRESS | Nxstage Medical, Inc. | 2014-02-04 | 168 | 0 |
| K131050 | NXSTAGE 1.6M2 DIALYZER | Nxstage Medical, Inc. | 2013-12-27 | 256 | 0 |
| K131739 | NXSTAGE CONNECTED HEALTH SYSTEM | Nxstage Medical, Inc. | 2013-10-10 | 119 | 0 |
| K130460 | NXSTAGE DOSING CALCULATOR | Nxstage Medical, Inc. | 2013-07-11 | 139 | 0 |
| K122051 | NXSTAGE SYSTEM ONE | Nxstage Medical, Inc. | 2013-04-23 | 285 | 0 |
| K123395 | NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS | Nxstage Medical, Inc. | 2013-03-07 | 122 | 0 |
| K113023 | STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER | Nxstage Medical, Inc. | 2012-12-21 | 437 | 0 |
| K111174 | NXSTAGE PUREFLOW SL | Nxstage Medical, Inc. | 2011-09-19 | 145 | 9 |
| K093069 | NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDG | Nxstage Medical, Inc. | 2010-10-23 | 388 | 0 |
| K090255 | BLOOD TUBING SETS (STERILE FLUID PATH) | Nxstage Medical, Inc. | 2009-02-10 | 8 | 0 |
| K080919 | NXSTAGE PUREFLOW SL | Nxstage Medical, Inc. | 2008-10-15 | 197 | 1 |
| K080807 | BLOOD TUBING SETS (STERILE FLUID PATH) | Nxstage Medical, Inc. | 2008-07-18 | 119 | 14 |
| K081043 | LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT | Nxstage Medical, Inc. | 2008-07-07 | 84 | 0 |
| K071263 | NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500 | Nxstage Medical, Inc. | 2007-08-24 | 109 | 0 |
| K061837 | NXSTAGE CARTRIDGE EXPRESS | Nxstage Medical, Inc. | 2006-07-31 | 32 | 1 |
| K060296 | NXSTAGE DIALYSATE PREPARATION MODULE | Nxstage Medical, Inc. | 2006-03-31 | 53 | 0 |
| K053286 | MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION | Nxstage Medical, Inc. | 2005-12-22 | 27 | 3 |
| K050525 | NXSTAGE SYSTEM ONE | Nxstage Medical, Inc. | 2005-06-24 | 114 | 1 |
| K050727 | MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS | Nxstage Medical, Inc. | 2005-06-13 | 84 | 0 |
| K043436 | NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 | Nxstage Medical, Inc. | 2005-03-17 | 94 | 0 |
| K042089 | NX STAGE WATER PURIFICATION SYSTEM | Nxstage Medical, Inc. | 2004-11-24 | 113 | 0 |
| K042045 | NXSTAGE PUREFLOW-B SOLUTION | Nxstage Medical, Inc. | 2004-08-27 | 28 | 1 |
| K041424 | NXSTAGE SYSTEM ONE | Nxstage Medical, Inc. | 2004-07-02 | 35 | 0 |
| K040696 | MODIFICATION TO NXSTAGE SYSTEM ONE | Nxstage Medical, Inc. | 2004-05-26 | 70 | 3 |
| K040074 | ONEVIEW INTERFACE | Nxstage Medical, Inc. | 2004-04-08 | 85 | 0 |
| K033386 | NXSTAGE PUREFLOW SOLUTION | Nxstage Medical, Inc. | 2003-11-26 | 34 | 0 |
| K032356 | NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS | Nxstage Medical, Inc. | 2003-10-28 | 90 | 0 |
| K030470 | NXSTAGE SYSTEM ONE | Nxstage Medical, Inc. | 2003-07-07 | 145 | 0 |
| K014152 | NXSTAGE CARTRIDGE EXPRESS | Nxstage Medical, Inc. | 2002-12-11 | 358 | 0 |
| K022913 | NXSTAGE PREMIXED DIALYSATE | Nxstage Medical, Inc. | 2002-10-21 | 48 | 0 |
| K020858 | NXSTAGE THERAPY SYSTEM | Nxstage Medical, Inc. | 2002-04-17 | 30 | 0 |
| K011269 | LIFEMATE MLA MULTI-LINE ADAPTOR; LIFEMATE SFR STERILE FLUID | Nxstage Medical, Inc. | 2002-03-04 | 312 | 0 |
| K013655 | NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100 | Nxstage Medical, Inc. | 2002-02-04 | 90 | 0 |
| K012832 | COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMAT | Nxstage Medical, Inc. | 2001-10-24 | 62 | 0 |
| K012510 | MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM | Nxstage Medical, Inc. | 2001-10-19 | 74 | 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