Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rigel Medical Electronics, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
196 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K884645 | PATIENT MONITOR RIGEL MODEL MULTICARE 429 | Rigel Medical Electronics, Inc. | 1989-02-02 | 87 | 0 |
| K875160 | RIGEL MODEL MULTICARE 409 | Rigel Medical Electronics, Inc. | 1988-06-28 | 196 | 0 |
| K850407 | NEONATAL MONITOR 309 | Rigel Medical Electronics, Inc. | 1985-04-18 | 73 | 0 |
| K850155 | ECG PATIENT MONITOR 302 | Rigel Medical Electronics, Inc. | 1985-03-01 | 45 | 0 |
| K850156 | ECG PATIENT MONITOR 301 | Rigel Medical Electronics, Inc. | 1985-03-01 | 45 | 0 |
| K843376 | ECG PATIENT MONITOR | Rigel Medical Electronics, Inc. | 1984-12-27 | 121 | 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