Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Metron Medical Australia, Pty, Ltd. · Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
63 daysmedian FDA review time
327 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132137 | MULTISTIM | Metron Medical Australia, Pty, Ltd. | 2013-09-12 | 63 | 0 |
| K124010 | ACCUSONIC ADVANTAGE | Metron Medical Australia, Pty, Ltd. | 2013-08-23 | 239 | 0 |
| K120171 | ACCUSONIC ADVANTAGE | Metron Medical Australia, Pty, Ltd. | 2012-05-04 | 105 | 0 |
| K030880 | VECTORSONIC, MODEL VU-270 | Metron Medical Australia, Pty, Ltd. | 2003-04-18 | 29 | 0 |
| K030648 | VECTORSURGE 5 MODEL 470 | Metron Medical Australia, Pty, Ltd. | 2003-03-28 | 28 | 0 |
| K030878 | ACCOUSONIC, MODEL AS-270 | Metron Medical Australia, Pty, Ltd. | 2003-03-28 | 8 | 0 |
| K030410 | ACCOUSONIC PLUS, MODEL AP-170 | Metron Medical Australia, Pty, Ltd. | 2003-02-20 | 13 | 0 |
| K020119 | VECTORSONIC, MODEL VU-200 | Metron Medical Australia, Pty, Ltd. | 2002-07-22 | 189 | 0 |
| K011955 | MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100 | Metron Medical Australia, Pty, Ltd. | 2001-07-16 | 24 | 0 |
| K001897 | MULTI-STIM, MODEL MS-100 | Metron Medical Australia, Pty, Ltd. | 2001-06-12 | 356 | 0 |
| K002058 | VECTORSURGE 5, MODEL VS-500 | Metron Medical Australia, Pty, Ltd. | 2001-05-29 | 327 | 0 |
| K010609 | ACCUSONIC, MODEL AS-260 | Metron Medical Australia, Pty, Ltd. | 2001-03-16 | 15 | 0 |
| K003260 | VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460 | Metron Medical Australia, Pty, Ltd. | 2001-02-22 | 127 | 0 |
| K010102 | SONIC MODEL SO-300 | Metron Medical Australia, Pty, Ltd. | 2001-02-09 | 28 | 0 |
| K000593 | SONIC, MODEL SO-100 | Metron Medical Australia, Pty, Ltd. | 2000-08-04 | 164 | 0 |
| K001370 | ACCUSONIC PLUS, MODEL AP-100 | Metron Medical Australia, Pty, Ltd. | 2000-07-17 | 77 | 0 |
| K993821 | VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT | Metron Medical Australia, Pty, Ltd. | 1999-12-09 | 27 | 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