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

GBI — Predicate Candidate Screening

17 FDA 510(k) clearances under this product code; the 50 most recent screened below.

37 daysmedian FDA review time

157 days90th percentile

17clearances measured

K-number	Device	Applicant	Decided	Review days
K880329	FACTOR II PROSTHETIC SILICONE ELASTOMER	Factor, Ii, Inc.	1988-06-01	127
K874279	AHH NATURAL BREAST FORM	Pacific Prosthetics, Inc.	1987-10-29	9
K872714	S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY	Roseburg SA	1987-07-21	11
K864785	AMOENA BREAST FORMS	Coloplast Corp.	1987-01-08	31
K864786	PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT	Coloplast Corp.	1987-01-08	31
K853822	AMOENA BREAST FORMS	Coloplast Corp.	1985-09-30	17
K851668	PROSTHESIS OR SURGICAL PADS	Virginia Hall, Inc.	1985-06-04	42
K842765	SILIMED BREAST FORM	Sil-Med Corp.	1984-08-17	32
K841559	CONFORMA	Beiersdorf, Inc.	1984-07-17	92
K841171	TRILICON BREASE PROSTHESIS DIFFERENT	Baurs Krey Assoc., Inc.	1984-04-25	37
K832151	PDM SILOXANE PROSTHETIC ORBIT	Delaware Prosthetics, Inc.	1983-12-19	167
K832152	PDM SILOXANE PROSTHETIC EAR	Delaware Prosthetics, Inc.	1983-12-09	157
K832153	PDM SILOXANE PROSTHETIC NOSE	Delaware Prosthetics, Inc.	1983-12-09	157
K831831	TRULIFE SILICONE BREAST FORM	Medeering, Ltd.	1983-06-30	23
K813416	EXTERNAL BREAST PROSTHESIS	Surgical Appliance Industries, Inc.	1982-01-18	42
K792372	IPOS BREAST PROSTHESIS	Ipos KG	1979-12-19	23
K770359	IMPLANTING OF POLYACRYLIC FIBERS	Allan V. Marse	1977-04-08	45

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