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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.