Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KDL — Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
233 daysmedian FDA review time
567 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241239 | OrganProtex HTK Solution | Bridge TO Life, Ltd. | 2025-01-24 | 266 | 0 |
| K221386 | PERF-GEN Pulsatile Perfusion Solution | Institut Georges Lopez | 2022-06-14 | 32 | 0 |
| K221387 | BEL-GEN Cold Storage Solution | Institut Georges Lopez | 2022-06-14 | 32 | 0 |
| K211842 | Servator M SALF Solution | S.A.L.F. Spa | 2021-12-20 | 188 | 0 |
| K192408 | Custodiol HTK Solution | Dr. Franz Kohler Chemie GmbH | 2020-04-24 | 233 | 1 |
| K170150 | Servator H SALF solution-1000 ml PVC free bags, Servator H S | S.A.L.F. Spa | 2017-10-20 | 276 | 0 |
| K121736 | PERF-GEN PULSATILE PERFUSION SOLUTION | Waters Medical Systems, LLC | 2013-08-16 | 429 | 0 |
| K121618 | BEL-GEN COLD STORAGE SOLUTION | Waters Medical Systems, LLC | 2013-06-14 | 378 | 0 |
| K091656 | SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, S | Organ Recovery Systems, Inc. | 2010-03-11 | 275 | 0 |
| K043461 | CUSTODIOL | Dr. Franz Kohler Chemie GmbH | 2005-02-28 | 75 | 0 |
| K020924 | CUSTODIOL HTK SOLUTION | Dr. Franz Kohler Chemie GmbH | 2003-01-06 | 291 | 0 |
| K955497 | GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMO | Cobe Renal Care, Inc. | 1997-09-25 | 664 | 0 |
| K944866 | VIASPAN (BELZER UW - CSS) | The Dupont Merck Pharmaceutical Co. | 1996-04-22 | 567 | 1 |
| K900492 | LABELING CHANGE - VIASPAN(TM) (BELZER UW) | The DU Pont Co. | 1990-03-20 | 46 | 0 |
| K891239 | MOP CATHETER | Bivona Medical Technologies | 1989-11-28 | 266 | 0 |
| K883782 | BELZER UW-CSS | Du Pont Critical Care | 1989-04-20 | 226 | 0 |
| K884609 | EURO-COLLINS SOLUTION SETS | Fresenius USA, Inc. | 1989-01-26 | 80 | 0 |
| K780470 | H.P. MEDICAL GRADE SILICONE TUBING | Dow Corning Corp. Healthcare Industries Materials | 1978-04-27 | 36 | 0 |
| K760922 | PERFUSION TUBING SET | Shiley, Inc. | 1976-11-19 | 22 | 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