Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Glycobiosciences, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K143527 | IPM Wound Gel Bio, IPM Derm Gel Bio | Glycobiosciences, Inc. | 2015-04-20 | 129 | 0 |
| K123193 | IPM WOUND GEL BIO | Glycobiosciences, Inc. | 2014-03-03 | 508 | 0 |
| K130781 | L.A.M. IPM WOUND GEL, IPM DERM GEL | Glycobiosciences, Inc. | 2014-02-14 | 330 | 0 |
| K123113 | L.A.M. IMP WOUND GEL | Glycobiosciences, Inc. | 2012-12-11 | 69 | 1 |
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