Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Glustitch, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
133 daysmedian FDA review time
371 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150032 | GluStitch Twist Tissue Adhesive | Glustitch, Inc. | 2016-01-14 | 371 | 0 |
| K083752 | GLUSEAL 90, MODEL GLU9010 | Glustitch, Inc. | 2009-02-23 | 68 | 0 |
| K071484 | PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040 | Glustitch, Inc. | 2007-10-10 | 133 | 0 |
| K030574 | GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER | Glustitch, Inc. | 2003-08-21 | 178 | 0 |
| K013446 | GLUSITE, MODEL GLU002 | Glustitch, Inc. | 2001-12-20 | 64 | 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