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

Secol Co. — Predicate Candidate Screening

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

37 daysmedian FDA review time

48 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days
K802790	SOLVALINE	Secol Co.	1981-02-13	101
K810111	CELLONA PLASTER VARNISH	Secol Co.	1981-02-04	19
K810110	COBBLER'S CHIP SPLINTS	Secol Co.	1981-01-26	10
K810109	METAL SPLINTS	Secol Co.	1981-01-26	10
K802794	PRO-OPHTA STICKS	Secol Co.	1980-12-22	48
K802793	LOMATUELL OINTMENT DRESSING	Secol Co.	1980-12-18	44
K802786	POROPLAST-EYE DRESSING	Secol Co.	1980-12-17	43
K802797	O.R. DRAPES	Secol Co.	1980-12-17	43
K802799	EYE PADS	Secol Co.	1980-12-17	43
K802787	METALLINE DRESSINGS	Secol Co.	1980-12-17	43
K802791	ZINC PASTE BANDAGE	Secol Co.	1980-12-17	43
K802798	OPRATEX ABDOMINAL PAD	Secol Co.	1980-12-11	37
K802785	ELASTIC BANDAGE	Secol Co.	1980-12-11	37
K802795	ORTHOPEDIC PADDING	Secol Co.	1980-12-10	36
K802784	ELASTIC OPEN WEAVE BANDAGE	Secol Co.	1980-12-10	36
K802792	CELLONA	Secol Co.	1980-12-10	36
K802789	TUBULAR BANDAGE	Secol Co.	1980-12-10	36
K802796	CELLAMIN	Secol Co.	1980-11-24	20

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