Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rln Systems, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
482 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K003745 | LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE | Rln Systems, Inc. | 2001-01-16 | 43 | 1 |
| K954601 | NERVE LOCATOR/MONITOR SYSTEM MODIFICATION | Rln Systems, Inc. | 1995-12-22 | 101 | 0 |
| K925008 | RLN NERVE LOCATOR/MONITOR; MODEL A | Rln Systems, Inc. | 1992-11-24 | 53 | 0 |
| K912508 | NERVE LOCATOR/MONITOR SYSTEM, MODIFICATION | Rln Systems, Inc. | 1992-09-30 | 482 | 0 |
| K895676 | HEMOSTAT/STIMULATOR PROBE | Rln Systems, Inc. | 1989-12-08 | 79 | 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