Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Laboratorios Grifols, S.A. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
23 daysmedian FDA review time
437 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162216 | GRI-FILL PERISTALTIC SET | Laboratorios Grifols, S.A. | 2017-10-19 | 437 | 0 |
| K102590 | FLEBOSET DOUBLE | Laboratorios Grifols, S.A. | 2011-01-13 | 126 | 0 |
| K093182 | SET GRI-FILL 3.0 | Laboratorios Grifols, S.A. | 2010-01-27 | 111 | 0 |
| K082752 | QUICKPIN | Laboratorios Grifols, S.A. | 2008-09-29 | 10 | 0 |
| K050339 | SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE | Laboratorios Grifols, S.A. | 2005-02-25 | 14 | 0 |
| K040456 | FLEBOSET MULTIPLE | Laboratorios Grifols, S.A. | 2004-03-09 | 15 | 0 |
| K033916 | GRI-BAG, GRI-BAG AP | Laboratorios Grifols, S.A. | 2003-12-30 | 12 | 1 |
| K033682 | SET GRI-FILL 2.0-1 WAY; 2.0-2 WAYS; LUER CONNECTION TUBE | Laboratorios Grifols, S.A. | 2003-12-17 | 23 | 0 |
| K031419 | GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML | Laboratorios Grifols, S.A. | 2003-11-24 | 203 | 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