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

Mentor Corp. — Predicate Candidate Screening

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

69 daysmedian FDA review time

244 days90th percentile

61clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K130813	MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH S	Mentor Corp.	2013-04-11	17	4
K053414	MENTOR NOVASILK MESH	Mentor Corp.	2005-12-27	20	0
K050008	MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER	Mentor Corp.	2005-06-03	151	0
K042851	MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT	Mentor Corp.	2004-11-09	25	0
K040959	MENTOR GENESIS PENILE PROSTHESIS	Mentor Corp.	2004-10-29	199	1
K031767	MENTOR OBTAPE TRANS-OBTURATOR TAPE	Mentor Corp.	2003-07-17	38	0
K011493	MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS	Mentor Corp.	2002-10-01	504	0
K011500	MENTOR CONTOUR PROFILE TISSUE EXPANDER	Mentor Corp.	2001-12-03	201	0
K004005	MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT),	Mentor Corp.	2001-10-12	290	0
K010709	MENTOR STERILE SALINE MAMMARY VOLUME SIZERS	Mentor Corp.	2001-04-23	45	1
K003873	MENTOR SELF-CATH CLOSED SYSTEM	Mentor Corp.	2001-03-29	104	0
K003784	MENTOR SELF-CATH PLUS	Mentor Corp.	2001-03-05	88	0
K993308	MENTOR EVACARE VAGINAL PESSARIES	Mentor Corp.	1999-12-13	70	0
K983065	MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM	Mentor Corp.	1998-12-01	90	0
K981527	MENTOR PATHWAY INTRODUCER/DILATOR	Mentor Corp.	1998-07-09	72	0
K980483	MENTOR SUSPEND SLING	Mentor Corp.	1998-04-30	80	0
K980050	MENTOR SKIN PROTECTION PAD	Mentor Corp.	1998-02-27	52	0
K974469	MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL	Mentor Corp.	1998-02-24	90	0
K970471	MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS)	Mentor Corp.	1997-07-17	160	0
K963066	MENTOR INJECTION PORT DETECTOR (IPD)	Mentor Corp.	1996-09-27	51	0
K962013	MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT	Mentor Corp.	1996-08-22	91	0
K945628	CLEAR ADVANTAGE II	Mentor Corp.	1995-07-06	232	0
K922346	FEMALE URINE SAMPLING DEVICE	Mentor Corp.	1992-08-14	87	0
K912919	MENTOR INFUSION LINE	Mentor Corp.	1991-12-13	163	0
K913524	SILICONE MALE EXTERNAL CATHETER	Mentor Corp.	1991-10-04	57	0
K912060	MENTOR BLACK LIGHT INJECTION STENT SET	Mentor Corp.	1991-09-27	141	0
K910790	MENTOR LUBRICATING JELLY	Mentor Corp.	1991-05-03	67	0
K905484	ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT	Mentor Corp.	1991-02-11	67	0
K894475	MENTOR TISSUE EXPANDERS W/TDMAC COATING	Mentor Corp.	1990-11-26	496	0
K900371	MENTOR MODIFIED MALLEABLE PENILE PROSTHESES	Mentor Corp.	1990-11-02	280	0
K895285	MENTOR DUCTAL CATHETERS	Mentor Corp.	1989-10-17	54	0
K890402	MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE)	Mentor Corp.	1989-08-03	191	0
K884250	RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.)	Mentor Corp.	1989-06-12	244	0
K883023	MODIFIED ULTRA-FRESH ODOR REDUCING COMPOUND	Mentor Corp.	1988-09-29	72	0
K883303	MENTOR RAPID-SPAN (TM) TISSUE EXPANDER	Mentor Corp.	1988-08-26	22	0
K875038	MENTOR UNISTENT URETERAL STENT SET	Mentor Corp.	1988-03-03	87	0
K871313	ULTRA-FRESH DEODORANT	Mentor Corp.	1988-03-02	336	0
K873557	MENTOR BLACK LIGHT URETERAL STENT SET	Mentor Corp.	1988-02-11	161	0
K874690	GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER	Mentor Corp.	1988-02-08	84	0
K863439	INTRAUTERINE HEMOSTASIS BALLOON STENT	Mentor Corp.	1987-06-02	270	0
K870059	MENTOR NIPPLE RECONSTRUCTION DEVICE	Mentor Corp.	1987-02-24	48	0
K863565	MENTOR ALLOPLASTIC SPERMATOCELE	Mentor Corp.	1986-11-19	68	0
K862539	SILICONE DOUBLE COIL URETERAL STENT WITH SUTURE	Mentor Corp.	1986-09-09	69	0
K862049	MENTOR FLAT-SPAN	Mentor Corp.	1986-06-10	12	0
K860055	MENTOR SINGLE COIL URINARY DIVERSION STENT SET	Mentor Corp.	1986-03-11	64	0
K860517	MENTOR CORPORAL DILATORS	Mentor Corp.	1986-03-11	28	0
K851870	MENTOR UNIVERSAL URETERAL STENT SET	Mentor Corp.	1985-07-02	64	0
K844813	MENTOR EXPANDER MAMMARY PROSTHESIS	Mentor Corp.	1985-05-10	150	0
K850355	MENTOR PERCUTANEOUS RENAL DILATOR SET	Mentor Corp.	1985-03-12	41	0
K850287	MENTOR PERCUTANEOUS MALECOT NEPHROSTOMY SET	Mentor Corp.	1985-03-07	42	0

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