Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mennen Greatbatch Electonics — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
10 daysmedian FDA review time
32 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K772000 | ECG TELEMETRY SYSTEM | Mennen Greatbatch Electonics | 1977-11-22 | 32 | 0 |
| K770832 | PORTASCOPE II | Mennen Greatbatch Electonics | 1977-06-03 | 28 | 0 |
| K770279 | MONITOR, PORTABLE, PART #431-010 | Mennen Greatbatch Electonics | 1977-02-24 | 10 | 0 |
| K770246 | ISOLATED EEG AMPLIFIER MODULE | Mennen Greatbatch Electonics | 1977-02-14 | 7 | 0 |
| K770247 | D.C. AMPLIFIER MODULE | Mennen Greatbatch Electonics | 1977-02-14 | 7 | 0 |
| K770245 | ABDOMINAL FETAL ECG MODULE | Mennen Greatbatch Electonics | 1977-02-14 | 7 | 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