Metron Medical Australia, Pty, Ltd.: FDA clearances and approvals
Metron Medical Australia, Pty, Ltd. has 17 FDA 510(k) clearances (first 1999, latest 2013), across 4 product codes in 2 review panels. Median 510(k) review time: 63 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 105 |
| 2013 | 2 | 151 |
| 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 |
|---|---|---|---|
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 9 | 9 |
| IPF | Stimulator, Muscle, Powered | 5 | 5 |
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | 2 | 2 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
Review panels
- Physical Medicine (16)
- Neurology (1)
Most recent Metron Medical Australia, Pty, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K132137 | MULTISTIM | IPF | 2013-09-12 | 63 |
| K124010 | ACCUSONIC ADVANTAGE | IMI | 2013-08-23 | 239 |
| K120171 | ACCUSONIC ADVANTAGE | IMI | 2012-05-04 | 105 |
| K030880 | VECTORSONIC, MODEL VU-270 | IMG | 2003-04-18 | 29 |
| K030878 | ACCOUSONIC, MODEL AS-270 | IMI | 2003-03-28 | 8 |
| K030648 | VECTORSURGE 5 MODEL 470 | IPF | 2003-03-28 | 28 |
| K030410 | ACCOUSONIC PLUS, MODEL AP-170 | IMI | 2003-02-20 | 13 |
| K020119 | VECTORSONIC, MODEL VU-200 | IMG | 2002-07-22 | 189 |
| K011955 | MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100 | IMI | 2001-07-16 | 24 |
| K001897 | MULTI-STIM, MODEL MS-100 | GZJ | 2001-06-12 | 356 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Metron Medical Australia, Pty, Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Metron Medical Australia, Pty, Ltd. have?
Metron Medical Australia, Pty, Ltd. has 17 FDA 510(k) clearances (first 1999, latest 2013), across 4 product codes in 2 review panels.
How long does FDA take to clear Metron Medical Australia, Pty, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Metron Medical Australia, Pty, Ltd.'s cleared 510(k)s is 63 days.
What devices does Metron Medical Australia, Pty, Ltd. make?
Its most frequent FDA product codes are IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat, 9); IPF (Stimulator, Muscle, Powered, 5); IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat, 2).
Has Metron Medical Australia, Pty, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Metron Medical Australia, Pty, Ltd. Related entities may recall under other names.
Next steps
- See all 17 Metron Medical Australia, Pty, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IMI, Metron Medical Australia, Pty, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.