Medtel Pty. , Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Medtel Pty. , Ltd.” (first 1979, latest 1983), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 25 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 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 4 | 4 |
| DSK | Computer, Blood-Pressure | 2 | 2 |
| BZN | Cart, Emergency, Cardiopulmonary (Excluding Equipment) | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
Review panels
- Cardiovascular (6)
- Anesthesiology (1)
- General Hospital (1)
Most recent Medtel Pty. , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K832356 | PORTABLE OPERAT. RM. MONITORS HS30/40 | BZN | 1983-10-28 | 102 |
| K820670 | HS17/HS18 SERIES MONITORS | FLL | 1982-04-09 | 29 |
| K820671 | CM10 CENTRAL MONITORING SYSTEM | DRT | 1982-04-01 | 21 |
| K820399 | HS20 PORT. OPERATING ROOM MONITOR | DRT | 1982-03-22 | 39 |
| K802184 | HS10 PORTABLE OPERATING ROOM MONITOR | DRT | 1980-09-26 | 16 |
| K800243 | D668 & D664 CENTRAL MONITORING SYSTEMS | DRT | 1980-04-10 | 65 |
| K791839 | H59 CRITICAL CARE MONITOR | DSK | 1979-10-01 | 17 |
| K791838 | HSH/H512 ADULT PHYSIOLOGICAL MONITORS | DSK | 1979-10-01 | 17 |
Recalls
openFDA lists no recalls under a recalling firm named Medtel Pty. , Ltd..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Medtel Pty. , Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Medtel Pty. , Ltd.” (first 1979, latest 1983), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medtel Pty. , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medtel Pty. , Ltd. is 25 days.
Which FDA product codes appear under Medtel Pty. , Ltd.?
The most frequent FDA product codes under this applicant name are DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 4); DSK (Computer, Blood-Pressure, 2); BZN (Cart, Emergency, Cardiopulmonary (Excluding Equipment), 1).
Next steps
- See all 8 Medtel Pty. , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DRT, Medtel Pty. , 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.