Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Gambro Renal Products, Inc. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
119 daysmedian FDA review time
307 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K133807 | MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS | Gambro Renal Products, Inc. | 2014-03-26 | 100 | 0 |
| K131516 | PRISMAFLEX SYSTEM 7.10 | Gambro Renal Products, Inc. | 2014-01-03 | 220 | 0 |
| K130039 | REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER | Gambro Renal Products, Inc. | 2013-05-02 | 115 | 4 |
| K113313 | MOLECULAR ADSORBENT RECIRCULATING(MARS) | Gambro Renal Products, Inc. | 2012-12-14 | 401 | 0 |
| K110823 | PRISMAFLEX | Gambro Renal Products, Inc. | 2011-06-17 | 85 | 0 |
| K103832 | PHOENIX HEMODIALYSIS DELIVERY SYSTEM | Gambro Renal Products, Inc. | 2011-05-20 | 141 | 0 |
| K100451 | GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J | Gambro Renal Products, Inc. | 2010-12-21 | 307 | 0 |
| K100364 | GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003 | Gambro Renal Products, Inc. | 2010-11-03 | 264 | 0 |
| K093608 | GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H | Gambro Renal Products, Inc. | 2010-07-29 | 251 | 0 |
| K080519 | PRISMAFLEX M150 SET | Gambro Renal Products, Inc. | 2008-06-13 | 109 | 3 |
| K072232 | GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL | Gambro Renal Products, Inc. | 2007-09-07 | 28 | 1 |
| K063183 | PRISMA M10 PRE SET | Gambro Renal Products, Inc. | 2007-02-15 | 119 | 0 |
| K040255 | POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGL | Gambro Renal Products, Inc. | 2004-05-24 | 110 | 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