Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Remote Diagnostic Technologies , Ltd. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
225 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K173768 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies , Ltd. | 2018-01-10 | 30 | 0 |
| K170567 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies , Ltd. | 2017-07-06 | 129 | 0 |
| K133973 | TEMPUS PRO WITH ENHANCED FEATURES | Remote Diagnostic Technologies , Ltd. | 2014-08-14 | 231 | 0 |
| K134014 | TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROB | Remote Diagnostic Technologies , Ltd. | 2014-08-12 | 225 | 0 |
| K133988 | TEMPUS PRO EXTENDED FEATURES | Remote Diagnostic Technologies , Ltd. | 2014-05-16 | 141 | 0 |
| K130773 | TEMPUS PRO PATIENT MONITOR | Remote Diagnostic Technologies , Ltd. | 2013-06-05 | 77 | 1 |
| K113105 | TEMPUSIC PATIENT MONITOR | Remote Diagnostic Technologies , Ltd. | 2011-12-15 | 56 | 0 |
| K101264 | TEMPUS IC PROFESSIONAL PATIENT MONITOR | Remote Diagnostic Technologies , Ltd. | 2010-05-11 | 6 | 1 |
| K082718 | TEMPUSIC PATIENT MONITOR | Remote Diagnostic Technologies , Ltd. | 2008-10-10 | 23 | 0 |
| K033410 | TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002 | Remote Diagnostic Technologies , Ltd. | 2004-03-05 | 130 | 0 |
| K010436 | TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORIN | Remote Diagnostic Technologies , Ltd. | 2001-05-14 | 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