Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shl Telemedicine International , Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
282 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K113514 | SMARTHEART | Shl Telemedicine International , Ltd. | 2012-02-22 | 86 | 0 |
| K080047 | CARDIOSEN'C | Shl Telemedicine International , Ltd. | 2008-07-11 | 185 | 0 |
| K063609 | RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER | Shl Telemedicine International , Ltd. | 2007-09-12 | 282 | 0 |
| K003392 | CARDIO MONITOR CENTER VISION; MODEL S-CV7-00 | Shl Telemedicine International , Ltd. | 2001-01-25 | 86 | 0 |
| K981807 | CARDIOVISION SOFTWARE, MODEL S-CV5-96 | Shl Telemedicine International , Ltd. | 1998-08-19 | 90 | 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