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

Mennen Medical, Inc. · Predicate Candidate Screening

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

117 daysmedian FDA review time

356 days90th percentile

34clearances measured

K-number	Device	Applicant	Decided	Review days
K030722	ENVOY PATIENT MONITOR	Mennen Medical, Inc.	2004-02-26	356
K983864	ETCO2 VITAL SIGNS MODULE	Mennen Medical, Inc.	1999-10-08	340
K991775	MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HO	Mennen Medical, Inc.	1999-06-24	30
K982697	MODIFICATION TO ENSEMBLE CENTRAL STATION MONITOR	Mennen Medical, Inc.	1998-08-12	9
K974510	ENVOY PATIENT MONITOR	Mennen Medical, Inc.	1998-04-14	134
K970358	ENSEMBLE CENTRAL STATION MONITOR	Mennen Medical, Inc.	1998-02-11	377
K940081	MERCURY	Mennen Medical, Inc.	1995-04-12	460
K940415	HORIZON 9000 WS	Mennen Medical, Inc.	1995-01-06	343
K920915	CAPNOMED 100 STAND-ALONE ETCO2 MODULE	Mennen Medical, Inc.	1993-03-23	390
K914381	HORIZON 9000/HIS OPTION AMPLIFIER	Mennen Medical, Inc.	1992-01-28	117
K913339	HORIZON PACEMAKER DETECTION SOFTWARE	Mennen Medical, Inc.	1992-01-08	166
K911257	MR-5200 FULL DISCLOSURE SYSTEM	Mennen Medical, Inc.	1991-08-19	151
K910945	HORIZON 2000 EEG MONITORING OPTION	Mennen Medical, Inc.	1991-08-15	162
K911616	HORIZON XL	Mennen Medical, Inc.	1991-07-10	90
K903524	HORIZON 2000 ST ANALYSIS OPTION	Mennen Medical, Inc.	1991-03-01	207
K901774	HORIZON 2000 PULSE OXIMETRY (SAO2) MONITOR CAPABIL	Mennen Medical, Inc.	1990-05-22	33
K895895	MODEL 219 TELEMETRY SYSTEM	Mennen Medical, Inc.	1990-02-22	139
K894918	HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP.	Mennen Medical, Inc.	1989-10-31	90
K893585	14 COLOR VIDEO DISPLAY 211-260-010	Mennen Medical, Inc.	1989-07-20	72
K893133	HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX	Mennen Medical, Inc.	1989-07-14	80
K892066	HORIZON CENTRAL STATION	Mennen Medical, Inc.	1989-06-22	84
K884423	HORIZON DISPLAY CONTROLLER PART # 266-200-010	Mennen Medical, Inc.	1989-05-31	224
K885204	HORIZON 2000 ARRHYTHMIA MONITOR OPTION - (ALARMS)	Mennen Medical, Inc.	1989-04-19	121
K884897	FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER	Mennen Medical, Inc.	1989-03-09	106
K885079	HORIZON 2000 TRANSCUTANEOUS GAS #26X-OPT-275	Mennen Medical, Inc.	1989-02-17	71
K882273	HORIZON 2000 PULSE OXIMETRY AND MODULE	Mennen Medical, Inc.	1988-08-25	86
K881273	HORIZON 2000 ARRHYTHMIA MONITORING OPTION	Mennen Medical, Inc.	1988-07-12	109
K875167	HORIZON 9000	Mennen Medical, Inc.	1988-05-31	167
K880595	HORIZON 2000/S 266-XXX-XXX	Mennen Medical, Inc.	1988-05-06	85
K864843	HORIZON 1100 CARDIAC MONITOR	Mennen Medical, Inc.	1987-03-16	96
K854942	HORIZON 2000 NON-INVASIVE BLOOD PRESSURE CAP.	Mennen Medical, Inc.	1986-06-02	174
K860124	HORIZON 2000 TRANSCUTANEOUS GAS MONITORING	Mennen Medical, Inc.	1986-05-09	115
K850880	HORIZON 1000 CARDIAC MONITOR	Mennen Medical, Inc.	1985-04-25	52
K850879	HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR	Mennen Medical, Inc.	1985-04-25	52

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