Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neptec Design Group, Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022274 | CARECOMPANION PATIENT STATION & NURSE STATION | Neptec Design Group, Ltd. | 2003-05-29 | 318 | 0 |
| K023286 | CARECOMPANION PATIENT STATION/CARECOMPANION PATIENT STATION | Neptec Design Group, Ltd. | 2003-05-02 | 212 | 0 |
| K020584 | N2000 BASE STATION; N2001 NURSE STATION | Neptec Design Group, Ltd. | 2002-05-22 | 90 | 0 |
| K012801 | N2000 BASE STATION, N2001 NURSE STATION | Neptec Design Group, Ltd. | 2001-11-14 | 85 | 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