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

The Owenby Co. — Predicate Candidate Screening

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

28 daysmedian FDA review time

44 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K801628	RESTRAINT, PROTECTIVE	The Owenby Co.	1980-08-07	23
K801532	STOCKINETTE, STERILE TWO PLY W/PULL TABS	The Owenby Co.	1980-07-28	27
K801627	COVER, LIMB	The Owenby Co.	1980-07-28	13
K801626	ARM SLING	The Owenby Co.	1980-07-28	13
K801531	ARM SLING	The Owenby Co.	1980-07-21	20
K790210	STOCKINETTE, TUBULAR UNBLEACHED	The Owenby Co.	1979-02-27	28
K780764	NON-STERILE FOLDED GAUZE	The Owenby Co.	1978-06-06	33
K780418	BURN DRESSING PAD	The Owenby Co.	1978-04-10	27
K770889	BURN DRESSING KIT	The Owenby Co.	1977-07-11	56
K761069	P.S.M. BOTIQUE CAP	The Owenby Co.	1976-12-30	44
K761068	P.S.M. BOUFFANT CAP	The Owenby Co.	1976-12-30	44
K761071	P.S.M. JUSTA KAP	The Owenby Co.	1976-12-30	44
K761070	P.S.M. SURGICAL HOOD	The Owenby Co.	1976-12-30	44
K761072	P.S.M. JUSTA COVER	The Owenby Co.	1976-12-02	16

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