Remote Diagnostic Technologies , Ltd.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Remote Diagnostic Technologies , Ltd.” (first 2001, latest 2018), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 77 |
| 2014 | 3 | 225 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 129 |
| 2018 | 1 | 30 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Remote Diagnostic Technologies , Ltd. took a median 80 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 195 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 5 | 5 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 3 | 3 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 | 2 |
| QYW | Hospital Cardiac Telemetry | 1 | 1 |
Review panels
- Cardiovascular (11)
Most recent Remote Diagnostic Technologies , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173768 | Tempus Pro Patient Monitor | MHX | 2018-01-10 | 30 |
| K170567 | Tempus Pro Patient Monitor | MHX | 2017-07-06 | 129 |
| K133973 | TEMPUS PRO WITH ENHANCED FEATURES | QYW | 2014-08-14 | 231 |
| K134014 | TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE) | MWI | 2014-08-12 | 225 |
| K133988 | TEMPUS PRO EXTENDED FEATURES | MWI | 2014-05-16 | 141 |
| K130773 | TEMPUS PRO PATIENT MONITOR | MWI | 2013-06-05 | 77 |
| K113105 | TEMPUSIC PATIENT MONITOR | MWI | 2011-12-15 | 56 |
| K101264 | TEMPUS IC PROFESSIONAL PATIENT MONITOR | MWI | 2010-05-11 | 6 |
| K082718 | TEMPUSIC PATIENT MONITOR | DXH | 2008-10-10 | 23 |
| K033410 | TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002 | DXH | 2004-03-05 | 130 |
1 earlier clearances. See the full list in Caduvo.
Recalls
13 product recalls in 13 recall events; 10 initiated in the last five years. Most recent: 2025-11-26.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Remote Technologies, Inc. (2 510(k)s)
- Remote Diagnostic Technologies Limited (1 510(k)s)
- Remote Diagnostic Technologies, Ltd. A Philips Company (1 510(k)s)
- Remote Diagnostics Technologies, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Remote Diagnostic Technologies , Ltd.?
FDA lists 11 510(k) clearances under the applicant name “Remote Diagnostic Technologies , Ltd.” (first 2001, latest 2018), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Remote Diagnostic Technologies , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Remote Diagnostic Technologies , Ltd. is 90 days.
Which FDA product codes appear under Remote Diagnostic Technologies , Ltd.?
The most frequent FDA product codes under this applicant name are MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), 5); DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 3); MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 2).
Next steps
- See all 11 Remote Diagnostic Technologies , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MWI, Remote Diagnostic Technologies , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.