Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mennen Medical , Ltd. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
263 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K141441 | MENNTOR X7 | Mennen Medical , Ltd. | 2015-01-09 | 221 | 0 |
| K131789 | CEREBRALOGIK- AEEG | Mennen Medical , Ltd. | 2013-12-27 | 192 | 0 |
| K123792 | HORIZON XVU (FFR) | Mennen Medical , Ltd. | 2013-08-30 | 263 | 0 |
| K093766 | VITALOGIK 6000/6500 | Mennen Medical , Ltd. | 2010-05-07 | 151 | 0 |
| K091165 | HORIZON XVU | Mennen Medical , Ltd. | 2009-08-07 | 107 | 0 |
| K083063 | BIS INTERFACE FOR VITALOGIK PATIENT MONITORS | Mennen Medical , Ltd. | 2008-12-16 | 63 | 0 |
| K081484 | HORIZON XVU | Mennen Medical , Ltd. | 2008-06-20 | 23 | 0 |
| K073140 | VITALOGIK MODEL 4000/4500 | Mennen Medical , Ltd. | 2007-11-21 | 14 | 0 |
| K071899 | BIS MODULE FOR ENVOY PATIENT MONITOR | Mennen Medical , Ltd. | 2007-10-22 | 105 | 0 |
| K071348 | EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM | Mennen Medical , Ltd. | 2007-09-07 | 116 | 0 |
| K070254 | HORIZON SE | Mennen Medical , Ltd. | 2007-04-19 | 83 | 0 |
| K052288 | VITALOGIK | Mennen Medical , Ltd. | 2005-12-20 | 119 | 0 |
| K043564 | HORIZON ANGIO CATHLAB | Mennen Medical , Ltd. | 2005-01-27 | 31 | 0 |
| K024245 | ENVOY PATIENT MONITOR | Mennen Medical , Ltd. | 2004-05-10 | 504 | 0 |
| K032997 | MODIFICATION TO: HORIZON 9000WS | Mennen Medical , Ltd. | 2003-10-15 | 20 | 0 |
| K023798 | MODIFICATION TO ENVOY PATIENT MONITOR | Mennen Medical , Ltd. | 2002-12-03 | 19 | 0 |
| K022168 | ENVOY | Mennen Medical , Ltd. | 2002-08-01 | 29 | 0 |
| K020632 | ENGUARD REMOTE PATIENT MONITOR | Mennen Medical , Ltd. | 2002-03-15 | 16 | 0 |
| K011784 | MODIFICATION TO ENVOY PATIENT MONITOR | Mennen Medical , Ltd. | 2001-08-16 | 69 | 0 |
| K001120 | ENVOY PATIENT MONITOR | Mennen Medical , Ltd. | 2001-05-08 | 396 | 0 |
| K000563 | MODIFICATION TO ENVOY PATIENT MONITOR | Mennen Medical , Ltd. | 2000-05-17 | 85 | 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