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

MRD — Predicate Candidate Screening

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

87 daysmedian FDA review time

212 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K243271	MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer	Mentor Worldwide, LLC	2025-01-13	89	0
K241552	MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer	Mentor Worldwide, LLC	2024-09-06	98	0
K203229	NATRELLE INSPIRA Single Use Sizers for Gel Implants	Allergan	2021-06-02	212	0
K200706	Sientra OPUS Silicone Gel Breast Implant Sizer	Sientra, Inc.	2020-11-16	243	0
K183163	Intraoperative, Single-Use, Sterile, Silicone Breast Sizer M	Motiva USA, LLC	2019-02-05	82	0
K151055	Mentor MemoryShape Resterilizable Gel Breast Implant Sizer S	Mentor Worldwide, LLC	2015-05-20	30	0
K131853	MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER	Mentor Worldwide, LLC	2013-07-17	26	0
K062421	MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER	Mentor Corporation	2006-10-10	53	1
K010709	MENTOR STERILE SALINE MAMMARY VOLUME SIZERS	Mentor Corp.	2001-04-23	45	1
K984106	MAMMARY SIZER, MAMMARY PROTHESIS SIZER	Specialty Surgical Products, Inc.	1999-02-12	87	0
K982258	MAMMARY SIZER	Specialty Surgical Products, Inc.	1998-09-08	74	0
K961356	MAMMARY SIZER	General Surgical Innovations	1996-09-23	168	0
K831566	CUI MAMMARY PROTHESIS SIZER	Cox-Uphuff Intl.	1983-08-12	88	1

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