Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HYI — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
27 daysmedian FDA review time
50 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K871286 | GRAM IODINE | Remel Co. | 1987-04-08 | 8 | 0 |
| K842733 | GRAM IODINE | E K Ind., Inc. | 1984-08-10 | 28 | 0 |
| K821977 | GRAMSTAIN SET | Granite Diagnostics, Inc. | 1982-07-22 | 16 | 0 |
| K811722 | PARA-PAK | Meridian Diagnostics, Inc. | 1981-07-15 | 27 | 0 |
| K791711 | IMPROVED GRAM STAIN REAGENTS | Carr-Scarborough Microbiologicals, Inc. | 1979-10-17 | 50 | 0 |
| K781584 | GRAM STAIN KIT | Bioscientific | 1978-10-10 | 22 | 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