Laboratorios Grifols, S.A.: FDA clearances and approvals
Laboratorios Grifols, S.A. has 9 FDA 510(k) clearances (first 2003, latest 2017), across 2 product codes in 1 review panel. Median 510(k) review time: 23 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 437 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Laboratorios Grifols, S.A.'s cleared 510(k)s took a median 437 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 199 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | 7 | 7 |
| KPE | Container, I.V. | 2 | 2 |
Review panels
- General Hospital (9)
Most recent Laboratorios Grifols, S.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162216 | GRI-FILL PERISTALTIC SET | LHI | 2017-10-19 | 437 |
| K102590 | FLEBOSET DOUBLE | LHI | 2011-01-13 | 126 |
| K093182 | SET GRI-FILL 3.0 | LHI | 2010-01-27 | 111 |
| K082752 | QUICKPIN | LHI | 2008-09-29 | 10 |
| K050339 | SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE | LHI | 2005-02-25 | 14 |
| K040456 | FLEBOSET MULTIPLE | LHI | 2004-03-09 | 15 |
| K033916 | GRI-BAG, GRI-BAG AP | KPE | 2003-12-30 | 12 |
| K033682 | SET GRI-FILL 2.0-1 WAY; 2.0-2 WAYS; LUER CONNECTION TUBE | LHI | 2003-12-17 | 23 |
| K031419 | GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML | KPE | 2003-11-24 | 203 |
Recalls
openFDA lists no recalls under a recalling firm named Laboratorios Grifols, S.A..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Laboratorios Grifols, S.A. have?
Laboratorios Grifols, S.A. has 9 FDA 510(k) clearances (first 2003, latest 2017), across 2 product codes in 1 review panel.
How long does FDA take to clear Laboratorios Grifols, S.A.'s 510(k)s?
The median time from FDA receipt to decision across Laboratorios Grifols, S.A.'s cleared 510(k)s is 23 days.
What devices does Laboratorios Grifols, S.A. make?
Its most frequent FDA product codes are LHI (Set, I.V. Fluid Transfer, 7); KPE (Container, I.V., 2).
Has Laboratorios Grifols, S.A. had device recalls?
openFDA lists no recalls under a recalling firm name matching Laboratorios Grifols, S.A. Related entities may recall under other names.
Next steps
- See all 9 Laboratorios Grifols, S.A. clearances with predicates and recalls
- Run predicate analysis for product code LHI, Laboratorios Grifols, S.A.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.