Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
New England Medical Instruments, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K955787 | DIGITRACE HOME VIDEO SYSTEM | New England Medical Instruments, Inc. | 1996-02-09 | 50 | 0 |
| K910771 | DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX | New England Medical Instruments, Inc. | 1991-12-18 | 299 | 0 |
| K910279 | MCSEER/MICRO CONTROLLER SLD ST EEG EVENT RECORDER | New England Medical Instruments, Inc. | 1991-09-04 | 224 | 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