Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Greene International Corp. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
25 daysmedian FDA review time
144 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K883827 | MASKS, VARIOUS TYPES OF SURGICAL MASKS | Greene International Corp. | 1988-11-17 | 69 | 0 |
| K883828 | CONE MASKS, VARIOUS TYPES OF SURGICAL CONE MASKS | Greene International Corp. | 1988-10-03 | 24 | 0 |
| K880484 | SURGICAL GARMENTS | Greene International Corp. | 1988-06-27 | 144 | 0 |
| K870617 | VARIOUS TYES OF SURGICAL GARMENTS | Greene International Corp. | 1987-03-09 | 25 | 0 |
| K843075 | UTILITY SCISSORS DISPOSABLE ITEMS | Greene International Corp. | 1984-09-05 | 30 | 0 |
| K843073 | FIXED VOL. DISPENSERS, ADJUST VOL-HUNPIP | Greene International Corp. | 1984-08-24 | 18 | 0 |
| K843074 | DISPOS. & SPONGE FORCEPS PEAN ARTERY | Greene International Corp. | 1984-08-17 | 11 | 0 |
| K842719 | STANDARD WHEELCHAIR | Greene International Corp. | 1984-07-25 | 12 | 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