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

Euro-Med Intl. · Predicate Candidate Screening

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

147 daysmedian FDA review time

147 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K883884	PROSTATIC CORE-CUT NEEDLE	Euro-Med Intl.	1988-12-05	83
K882404	KEVOR-CURETTE	Euro-Med Intl.	1988-07-08	28
K854894	SPOON	Euro-Med Intl.	1986-05-02	147
K854891	KNIFE	Euro-Med Intl.	1986-05-02	147
K854898	ATLANTIC GRASPER	Euro-Med Intl.	1986-05-02	147
K854897	MAX-I-GRASP	Euro-Med Intl.	1986-05-02	147
K854895	BASKET FORCEP	Euro-Med Intl.	1986-05-02	147
K854901	PACIFIC GRASPER	Euro-Med Intl.	1986-05-02	147
K854890	HOOK PROBE	Euro-Med Intl.	1986-05-02	147
K854896	HOOK SCISSOR	Euro-Med Intl.	1986-05-02	147
K854889	FLEX-I-GRASP	Euro-Med Intl.	1986-02-21	77
K854892	RULER	Euro-Med Intl.	1985-12-24	18
K854893	KEYES SKIN PUNCH	Euro-Med Intl.	1985-12-24	18
K854888	RANDALL CURETTE	Euro-Med Intl.	1985-12-24	18
K854900	EPISIOTOMY SCISSORS	Euro-Med Intl.	1985-12-24	18
K854899	NOVAK CURETTE	Euro-Med Intl.	1985-12-24	18

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