Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

C. Intl. — Predicate Candidate Screening

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

87 daysmedian FDA review time

91 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K792494	CATHETERIZATION FORCEP	C. Intl.	1979-12-20	16
K790855	SURGICAL DRAPE CLIP #201	C. Intl.	1979-08-03	91
K790852	VAGI-SPEC	C. Intl.	1979-07-30	87
K790851	VAGI-PRESS #401	C. Intl.	1979-07-30	87
K790853	EASY-SPEC	C. Intl.	1979-07-30	87
K790854	FORCEPS #101 AND #102	C. Intl.	1979-06-05	32
K790856	PROCTOSCOPE #501	C. Intl.	1979-05-29	25

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