Glycar, Inc.: FDA clearances and approvals
Glycar, Inc. has 5 FDA 510(k) clearances (first 1994, latest 1997), across 3 product codes in 2 review panels. Median 510(k) review time: 176 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 2 | 2 |
| FTL | Mesh, Surgical, Polymeric | 2 | 2 |
| FTM | Mesh, Surgical | 1 | 1 |
Review panels
Most recent Glycar, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K963967 | GLYCAR PERICARDIAL PATCH | DXZ | 1997-10-31 | 394 |
| K963368 | GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLE | DXZ | 1997-10-31 | 430 |
| K963175 | GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING | FTM | 1996-09-23 | 40 |
| K954665 | GLYCAR STAPLE STRIPS | FTL | 1996-02-14 | 127 |
| K942911 | GLYCAR TISSUE REPAIR PATCH | FTL | 1994-12-14 | 176 |
Recalls
openFDA lists no recalls under a recalling firm named Glycar, Inc..
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 Glycar, Inc. have?
Glycar, Inc. has 5 FDA 510(k) clearances (first 1994, latest 1997), across 3 product codes in 2 review panels.
How long does FDA take to clear Glycar, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Glycar, Inc.'s cleared 510(k)s is 176 days.
What devices does Glycar, Inc. make?
Its most frequent FDA product codes are DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene, 2); FTL (Mesh, Surgical, Polymeric, 2); FTM (Mesh, Surgical, 1).
Has Glycar, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Glycar, Inc. Related entities may recall under other names.
Next steps
- See all 5 Glycar, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXZ, Glycar, Inc.'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.