Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Reynolds Medical , Ltd. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
105 daysmedian FDA review time
395 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K024283 | CARDIODIRECT, MODELS 12M, 12I, 12S | Reynolds Medical , Ltd. | 2003-08-01 | 221 | 0 |
| K013367 | CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH | Reynolds Medical , Ltd. | 2001-12-13 | 64 | 0 |
| K011345 | CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM | Reynolds Medical , Ltd. | 2001-07-20 | 79 | 0 |
| K011837 | LIFECARD CF 7 DAY | Reynolds Medical , Ltd. | 2001-07-13 | 31 | 0 |
| K001025 | LIFECARD CF COMPACT RECORDER | Reynolds Medical , Ltd. | 2000-04-19 | 20 | 0 |
| K991211 | EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM | Reynolds Medical , Ltd. | 1999-07-08 | 90 | 0 |
| K972649 | CARDIOCALL CARDIAC EVENT RECORDER | Reynolds Medical , Ltd. | 1997-12-04 | 142 | 1 |
| K951902 | PATHFINDER 700 HOLTER ANALYZER | Reynolds Medical , Ltd. | 1996-07-15 | 448 | 1 |
| K943278 | TRACKER 2/TRACKER 3 HOLTER RECORDER | Reynolds Medical , Ltd. | 1994-10-20 | 105 | 0 |
| K884126 | E-RAM | Reynolds Medical , Ltd. | 1989-10-30 | 395 | 0 |
| K871344 | PATHFINDER 3, AUTO SURVEYOR AND SURVEYOR | Reynolds Medical , Ltd. | 1987-10-20 | 197 | 0 |
| K821516 | TRACKER-2 CHANNEL ECG TAPE RECORDER | Reynolds Medical , Ltd. | 1982-05-28 | 7 | 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