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

LIL — Predicate Candidate Screening

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

70 daysmedian FDA review time

196 days90th percentile

26clearances measured

K-number	Device	Applicant	Decided	Review days
K061676	RIGIDOMETER, MODEL DIR-4U	Uroan 21	2006-12-27	196
K062042	PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM)	Plethora Solutions	2006-09-06	49
K052929	PREFTEST PROFESSIONAL SUITE	Limestone Technologies, Inc.	2006-04-26	189
K033126	MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM	Behavioral Technology, Inc.	2003-10-29	29
K000194	DIGITAL INFLECTION RIGIDOMETER (DIR)	Uroan Xxi Electromedicina	2000-04-10	80
K991479	VISER PENILE TUMESCENCE MONITOR	Laborie Medical Tech Corp.	1999-07-07	70
K980627	NEVA SYSTEM	Urometrics, Inc.	1998-04-07	48
K936115	CAT-600 PENILE PLETHYSMOGRAPH	Farrall Instruments, Inc.	1995-01-10	690
K940128	CAT-400UL PENILE PLETHYSMOGRAPH	Farrall Instruments, Inc.	1995-01-10	365
K941781	RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM	Dacomed Corp.	1994-08-25	136
K925931	RT2 RIGIDITY AND TUMESCENCE TEST	Compass Medical Technologies, Inc.	1992-12-21	28
K880903	BARD (R) ESKA ERECTIOMETER	C.R. Bard, Inc.	1988-05-06	65
K875333	SURGITEK NPT MONITOR	Surgitek	1988-04-13	105
K870983	NOCTURNAL PENILE TUMESCENCE MONITOR	Texas Medical Electronics Co.	1987-06-23	105
K851646	VIBRECTOR	Multicept, Aps.	1985-08-21	124
K841879	LFT - 212	Medical Monitoring Systems, Inc.	1984-07-26	80
K841202	DACOMED RIGISCAN SYSTEM	Dacomed Corp.	1984-07-06	107
K833454	BIOREM 3000 & 4000	Biorem	1984-02-21	146
K832121	DACOMED SNAP-GAUGE	Dacomed Corp.	1983-07-18	18
K831251	TUMISENSOR 1524	Life-Tech Intl., Inc.	1983-06-03	46
K831252	TUMISTORE RECORDER 1311	Life-Tech Intl., Inc.	1983-05-18	30
K830221	BEDSIDE N.P.T. 9900 - PRINTER 9800	Browne Medical, Inc.	1983-03-17	52
K830158	OREXAS POTENTEST	Orexas Medical Corp.	1983-02-07	20
K822099	BIOREM 2000	Biorem	1982-08-27	42
K820615	DACOMED SNAP-GAUGE	Dacomed Corp.	1982-04-21	44
K810944	PENILE ERECTION MONITOR	Medical Monitoring Systems, Inc.	1981-04-23	16

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