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

Gi Supply — Predicate Candidate Screening

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

147 daysmedian FDA review time

338 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K191923	EverLift Submucosal Lifting Agent	Gi Supply	2020-06-20	338
K031360	GI SUPPLY BILIARY STENT	Gi Supply	2003-09-24	147
K012411	HP-ONE	Gi Supply	2001-09-25	57
K970186	GI SUPPLY PARACENTESIS PUMP	Gi Supply	1997-02-14	28
K970187	RUNYON LARGE VOLUME PARACENTESIS KIT	Gi Supply	1997-02-14	28
K944903	HP-FAST	Gi Supply	1995-04-20	198
K931044	OXY-BLOC	Gi Supply	1993-10-04	217
K915816	BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY	Gi Supply	1992-03-27	88

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