Mennen Greatbatch Electonics: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Mennen Greatbatch Electonics” (first 1977, latest 1977), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 8 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 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 |
|---|---|---|---|
| DPS | Electrocardiograph | 1 | 1 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 | 1 |
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | 1 | 1 |
| DXJ | Display, Cathode-Ray Tube, Medical | 1 | 1 |
| GWQ | Full-Montage Standard Electroencephalograph | 1 | 1 |
| KXN | Monitor, Cardiac, Fetal | 1 | 1 |
Review panels
- Cardiovascular (4)
- Neurology (1)
- Obstetrics and Gynecology (1)
Most recent Mennen Greatbatch Electonics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K772000 | ECG TELEMETRY SYSTEM | DRG | 1977-11-22 | 32 |
| K770832 | PORTASCOPE II | DPS | 1977-06-03 | 28 |
| K770279 | MONITOR, PORTABLE, PART #431-010 | DXJ | 1977-02-24 | 10 |
| K770247 | D.C. AMPLIFIER MODULE | DRQ | 1977-02-14 | 7 |
| K770246 | ISOLATED EEG AMPLIFIER MODULE | GWQ | 1977-02-14 | 7 |
| K770245 | ABDOMINAL FETAL ECG MODULE | KXN | 1977-02-14 | 7 |
Recalls
openFDA lists no recalls under a recalling firm named Mennen Greatbatch Electonics.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Mennen Medical, Inc. (55 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mennen Greatbatch Electonics?
FDA lists 6 510(k) clearances under the applicant name “Mennen Greatbatch Electonics” (first 1977, latest 1977), across 6 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mennen Greatbatch Electonics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mennen Greatbatch Electonics is 8 days.
Which FDA product codes appear under Mennen Greatbatch Electonics?
The most frequent FDA product codes under this applicant name are DPS (Electrocardiograph, 1); DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency, 1); DRQ (Amplifier And Signal Conditioner, Transducer Signal, 1).
Next steps
- See all 6 Mennen Greatbatch Electonics clearances with predicates and recalls
- Run predicate analysis for product code DPS, Mennen Greatbatch Electonics's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.