Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Gallini U.S., LLC — Predicate Candidate Screening

10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

82 daysmedian FDA review time
140 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K992499GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLEGallini U.S., LLC1999-08-12170
K990645GALLINI ATRA-CUT NEEDLEGallini U.S., LLC1999-05-19820
K990716GALLINI BYCUT NEEDLEGallini U.S., LLC1999-05-17740
K981301SPEED-CUT AUTOMATIC BIOPSY SYSTEMGallini U.S., LLC1998-07-08900
K980676SPIGAL NEEDLEGallini U.S., LLC1998-05-21900
K980479QUICK-CUT AUTOMATIC BIOPSY SYSTEMGallini U.S., LLC1998-05-06890
K980248ACRI R NEEDLEGallini U.S., LLC1998-02-18260
K974440IBIGallini U.S., LLC1998-01-30660
K973152GALLINI ABS DEVICEGallini U.S., LLC1998-01-091400
K972266GALLINI COAXIAL INTRODUCERGallini U.S., LLC1997-07-29420

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