Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gambro Renal Products · Predicate Candidate Screening
24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
152 daysmedian FDA review time
315 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120333 | PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEME | Gambro Renal Products | 2012-05-25 | 112 | 0 |
| K072908 | PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEME | Gambro Renal Products | 2008-02-04 | 115 | 1 |
| K070414 | GAMBRO CARTRIDGE BLOOD SETS | Gambro Renal Products | 2007-10-12 | 242 | 2 |
| K063290 | GAMBRO QUICKSET BLOODLINES | Gambro Renal Products | 2007-01-30 | 90 | 0 |
| K062090 | PRISMA SYSTEM R03.10A | Gambro Renal Products | 2006-10-18 | 86 | 0 |
| K060195 | GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE U | Gambro Renal Products | 2006-04-24 | 89 | 2 |
| K051520 | GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H | Gambro Renal Products | 2005-12-09 | 184 | 0 |
| K052253 | MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE | Gambro Renal Products | 2005-11-02 | 76 | 0 |
| K043342 | POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND M | Gambro Renal Products | 2005-05-27 | 172 | 0 |
| K033262 | MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS) | Gambro Renal Products | 2005-05-27 | 596 | 0 |
| K042797 | WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS | Gambro Renal Products | 2005-03-09 | 152 | 0 |
| K042938 | GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS | Gambro Renal Products | 2005-01-06 | 73 | 6 |
| K040301 | GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A | Gambro Renal Products | 2004-11-01 | 266 | 0 |
| K041005 | GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS | Gambro Renal Products | 2004-10-07 | 171 | 6 |
| K023615 | GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR | Gambro Renal Products | 2003-05-06 | 190 | 0 |
| K010805 | PRISMA SYSTEM | Gambro Renal Products | 2002-08-06 | 508 | 1 |
| K013448 | PRISMASATE | Gambro Renal Products | 2002-01-15 | 90 | 0 |
| K013724 | BICART | Gambro Renal Products | 2002-01-08 | 60 | 0 |
| K003957 | DIACLEAR ULTRAFILTER | Gambro Renal Products | 2001-11-01 | 315 | 0 |
| K011221 | PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET | Gambro Renal Products | 2001-10-31 | 194 | 2 |
| K010985 | GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, | Gambro Renal Products | 2001-10-10 | 191 | 0 |
| K011368 | DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS | Gambro Renal Products | 2001-08-02 | 90 | 0 |
| K010667 | GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R | Gambro Renal Products | 2001-06-04 | 90 | 0 |
| K001156 | PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR H | Gambro Renal Products | 2000-07-07 | 88 | 2 |
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