Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GLY — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
122 daysmedian FDA review time
251 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050014 | HEMONIR TM | Nir Diagnostics, Inc. | 2005-05-05 | 122 | 0 |
| K993104 | STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CON | Nova Biomedical Corp. | 1999-12-02 | 77 | 0 |
| K955013 | NOVA CO-OXIMETER ANALYZER | Nova Biomedical Corp. | 1996-04-25 | 176 | 0 |
| K952725 | MULTICHECK | Radiometer America, Inc. | 1996-02-20 | 251 | 0 |
| K895466 | AVL MODEL 912 CO-OXYLITE | Avl Scientific Corp. | 1989-11-06 | 56 | 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