Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Telescan Medical Systems · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
110 daysmedian FDA review time
363 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K942586 | CARDIAC EVENT RECORDER (INSTANT MEMORY 2000) | Telescan Medical Systems | 1995-05-10 | 363 | 0 |
| K924187 | INSTANT MEMORY 2000 | Telescan Medical Systems | 1993-06-16 | 300 | 0 |
| K883358 | TELESCAN INSTANT MEMORY ECG RECORDER MODEL T-35CM | Telescan Medical Systems | 1988-10-13 | 65 | 0 |
| K871587 | THE TELESCAN C.A.R.E. SYSTEM | Telescan Medical Systems | 1987-08-12 | 110 | 0 |
| K820276 | TELESCAN T-30 | Telescan Medical Systems | 1982-02-12 | 10 | 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