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

KCZ — Predicate Candidate Screening

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

56 daysmedian FDA review time

188 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K990458	STRAUMANN EXTRAORAL IMPLANT SYSTEM	Straumann USA	1999-04-16	63
K951324	MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS	Maxol Limited L.C.	1995-05-26	64
K933465	COSMET	Great Bay Medical Products, Inc.	1994-07-20	369
K932978	CALSSIQUE OR MYSTIQUE	Dekumed, Kunststofftechnik Degler GmbH	1993-12-22	188
K932899	CLASSIQUE	Hemispheres Marketing Co. , Ltd.	1993-12-16	185
K933668	ALMOST U, INC. BREAST PROSTHESIS	Almost U., Inc.	1993-12-10	135
K921535	SUOENA AFFINITY (TM) MODEL #802	Coloplast Corp.	1992-05-11	41
K915382	AMOENA AFFINITY MODEL #802	Coloplast Corp.	1992-01-14	46
K911247	YOURS TRULY ASYMMETRICAL BREAST FORM	Jobst Institute, Inc.	1991-03-29	8
K904085	ELLA BREAST FORM	Coloplast A/S	1990-10-31	56
K904316	NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT	Coloplast Corp.	1990-10-11	20
K904086	DISCRENE SELF-SUPPORTING BREAST FORM	Coloplast A/S	1990-10-02	27
K896533	SPENCO BREAST FORMS	Spenco Medical Corp.	1989-12-13	29

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