Mennen Medical, Inc.: FDA clearances and approvals
Mennen Medical, Inc. has 55 FDA 510(k) clearances (first 1985, latest 2015), across 25 product codes in 4 review panels. Median 510(k) review time: 107 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 228 |
| 2014 | 0 | — |
| 2015 | 1 | 221 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | 13 | 13 |
| DQK | Computer, Diagnostic, Programmable | 5 | 5 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 4 | 4 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 4 | 4 |
| DPS | Electrocardiograph | 3 | 3 |
| DQA | Oximeter | 3 | 3 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 2 | 2 |
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | 2 | 2 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 | 2 |
| OLW | Index-Generating Electroencephalograph Software | 2 | 2 |
Plus 15 more product codes.
Review panels
- Cardiovascular (39)
- Anesthesiology (9)
- Neurology (6)
- Radiology (1)
Most recent Mennen Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141441 | MENNTOR X7 | DSI | 2015-01-09 | 221 |
| K131789 | CEREBRALOGIK- AEEG | OMA | 2013-12-27 | 192 |
| K123792 | HORIZON XVU (FFR) | DQX | 2013-08-30 | 263 |
| K093766 | VITALOGIK 6000/6500 | DSI | 2010-05-07 | 151 |
| K091165 | HORIZON XVU | DQK | 2009-08-07 | 107 |
| K083063 | BIS INTERFACE FOR VITALOGIK PATIENT MONITORS | OLW | 2008-12-16 | 63 |
| K081484 | HORIZON XVU | DQK | 2008-06-20 | 23 |
| K073140 | VITALOGIK MODEL 4000/4500 | DSI | 2007-11-21 | 14 |
| K071899 | BIS MODULE FOR ENVOY PATIENT MONITOR | OLW | 2007-10-22 | 105 |
| K071348 | EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM | DQK | 2007-09-07 | 116 |
45 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mennen Medical, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Mennen Medical, Inc. have?
Mennen Medical, Inc. has 55 FDA 510(k) clearances (first 1985, latest 2015), across 25 product codes in 4 review panels.
How long does FDA take to clear Mennen Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Mennen Medical, Inc.'s cleared 510(k)s is 107 days.
What devices does Mennen Medical, Inc. make?
Its most frequent FDA product codes are DSI (Detector And Alarm, Arrhythmia, 13); DQK (Computer, Diagnostic, Programmable, 5); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 4).
Has Mennen Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Mennen Medical, Inc. Related entities may recall under other names.
Next steps
- See all 55 Mennen Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSI, Mennen Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.