Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gallini Intl., Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
147 daysmedian FDA review time
224 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970872 | PAN (CHIBA ASPIRATING NEEDLE) | Gallini Intl., Inc. | 1997-05-21 | 72 | 0 |
| K970871 | TR NEEDLE | Gallini Intl., Inc. | 1997-05-21 | 72 | 0 |
| K964777 | TZ | Gallini Intl., Inc. | 1997-01-03 | 37 | 0 |
| K962570 | ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE | Gallini Intl., Inc. | 1996-11-27 | 149 | 0 |
| K962569 | BIOMID BONE MARROW BIOPSY NEEDLE | Gallini Intl., Inc. | 1996-11-27 | 149 | 0 |
| K962568 | ACRI ILIAC CREST ASPIRATION BIOPSY NEEDLES | Gallini Intl., Inc. | 1996-11-25 | 147 | 0 |
| K961407 | SPEED-CUT | Gallini Intl., Inc. | 1996-11-21 | 224 | 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