Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neurocom International, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
98 daysmedian FDA review time
511 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K946229 | BALANCE MANAGER | Neurocom International, Inc. | 1995-08-04 | 225 | 0 |
| K901732 | EMG ACCESSORY FOR POSTUROGRAPHY | Neurocom International, Inc. | 1991-09-10 | 511 | 0 |
| K871652 | NEUROCOM PRESSURE TEST SYSTEM | Neurocom International, Inc. | 1987-07-16 | 79 | 0 |
| K863443 | DUAL FORCEPLATE | Neurocom International, Inc. | 1986-09-17 | 12 | 0 |
| K851744 | EQUITEST | Neurocom International, Inc. | 1985-08-05 | 98 | 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