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

Roseburg SA — Predicate Candidate Screening

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

34 daysmedian FDA review time

225 days90th percentile

24clearances measured

K-number	Device	Applicant	Decided	Review days
K931155	STAPLE, FIXATION BONE; SCREW FIXATION BONE	Roseburg SA	1994-09-01	541
K890081	CALIUS-ISABEL CANOVAS SUNGLASSES	Roseburg SA	1989-03-09	58
K885275	ASSENAT-BLESCHET SUNGLASSES	Roseburg SA	1989-01-24	28
K882392	BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES	Roseburg SA	1988-08-26	77
K872715	UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY	Roseburg SA	1987-12-07	150
K874317	POIRIER KID-ROLLER MANUAL WHEELCHAIR	Roseburg SA	1987-11-17	27
K872714	S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY	Roseburg SA	1987-07-21	11
K871689	SPECTACLE FRAME - LORRAINE	Roseburg SA	1987-05-29	30
K871688	SPECTACLE FRAME - DANIELLE	Roseburg SA	1987-05-29	30
K870654	EFER ARTHROSCOPE	Roseburg SA	1987-05-14	90
K864436	STAVIP 3000	Roseburg SA	1987-03-16	124
K864791	POIRIER POWERED WHEELCHAIR	Roseburg SA	1987-02-04	58
K864790	POIRIER MANUAL WHEELCHAIR	Roseburg SA	1986-12-17	9
K860953	SUNGLASSES (NON-PRESCRIPTION)	Roseburg SA	1986-10-24	225
K860954	SPECTACLES FRAME	Roseburg SA	1986-03-31	18
K860955	SPECTACLES LENS	Roseburg SA	1986-03-31	18
K851560	PORTASPIR II	Roseburg SA	1985-12-13	241
K850294	CANAL FINDER	Roseburg SA	1985-06-04	131
K851555	OPTHALMIC BAR PRISM	Roseburg SA	1985-05-23	37
K851558	SURGICAL CAP CALOT	Roseburg SA	1985-04-30	14
K851554	OVERSHOES (SURCHAUSSURES	Roseburg SA	1985-04-30	14
K851559	TURQUOISE	Roseburg SA	1985-04-30	14
K851556	OP-FACE MASK(MASQUE DE CHIRUGIE)	Roseburg SA	1985-04-30	14
K850312	GYNASPYR VACUUM CURETTAGE UNIT	Roseburg SA	1985-02-28	34

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