Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FKT — Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
86 daysmedian FDA review time
289 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123835 | 2008 HEMODIALYSIS SORBENT SYSTEM | Renal Solutions, Inc. | 2013-02-15 | 64 | 0 |
| K093362 | 2008 HEMODIALYSIS SORBENT SYSTEM | Renal Solutions, Inc. | 2010-08-13 | 289 | 0 |
| K070739 | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 | Renal Solutions, Inc. | 2007-05-25 | 70 | 0 |
| K060381 | ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100 | Renal Solutions, Inc. | 2006-05-24 | 99 | 0 |
| K043574 | ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 | Renal Solutions, Inc. | 2005-06-03 | 158 | 0 |
| K031099 | SORB+HISORB+CARTRIDGE | Renal Solutions, Inc. | 2003-09-17 | 163 | 0 |
| K954623 | REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MON | Gambro Healthcare | 1996-08-28 | 328 | 0 |
| K882428 | REDY 2000 | Organon Teknika Corp. | 1988-10-25 | 134 | 0 |
| K874137 | MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CAR | Ash Medical Systems, Inc. | 1988-04-08 | 178 | 0 |
| K870270 | MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART. | Ash Medical Systems, Inc. | 1987-02-25 | 29 | 0 |
| K864179 | BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR | Ash Medical Systems, Inc. | 1986-12-11 | 48 | 0 |
| K851188 | PACKETS FOR PREP. OF DIALYSATES & INFUSATES - | Organon Teknika Corp. | 1985-04-12 | 43 | 0 |
| K842513 | HEMOPERFUSION PROCEDURE W/REDY 2000 | Organon Teknika Corp. | 1984-09-12 | 78 | 0 |
| K813574 | SORB II | Organon Teknika Corp. | 1982-03-23 | 90 | 0 |
| K812869 | D-3260 SORBENT CARTRIDGE | Organon Teknika Corp. | 1981-12-08 | 55 | 0 |
| K811170 | D-3160 SORBENT CARTRIDGE | Organon Teknika Corp. | 1981-07-31 | 94 | 0 |
| K801385 | K1 POTASSIUM ACETATE ADDITIVE | Organon Teknika Corp. | 1980-07-21 | 38 | 0 |
| K801440 | SORB 10 DIALYSATE INFUSATE C1 INFUSATE | Organon Teknika Corp. | 1980-07-21 | 31 | 0 |
| K792137 | SORB SYSTEM URS | Organon Teknika Corp. | 1980-01-16 | 86 | 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