Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medtel Pty. , Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
102 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K832356 | PORTABLE OPERAT. RM. MONITORS HS30/40 | Medtel Pty. , Ltd. | 1983-10-28 | 102 | 0 |
| K820670 | HS17/HS18 SERIES MONITORS | Medtel Pty. , Ltd. | 1982-04-09 | 29 | 0 |
| K820671 | CM10 CENTRAL MONITORING SYSTEM | Medtel Pty. , Ltd. | 1982-04-01 | 21 | 0 |
| K820399 | HS20 PORT. OPERATING ROOM MONITOR | Medtel Pty. , Ltd. | 1982-03-22 | 39 | 0 |
| K802184 | HS10 PORTABLE OPERATING ROOM MONITOR | Medtel Pty. , Ltd. | 1980-09-26 | 16 | 0 |
| K800243 | D668 & D664 CENTRAL MONITORING SYSTEMS | Medtel Pty. , Ltd. | 1980-04-10 | 65 | 0 |
| K791838 | HSH/H512 ADULT PHYSIOLOGICAL MONITORS | Medtel Pty. , Ltd. | 1979-10-01 | 17 | 0 |
| K791839 | H59 CRITICAL CARE MONITOR | Medtel Pty. , Ltd. | 1979-10-01 | 17 | 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