Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sound Surgical Technologies, LLC — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
228 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120328 | ORIGINS LIPOHARVESTING SYSTEM | Sound Surgical Technologies, LLC | 2012-09-17 | 228 | 0 |
| K110306 | SOUND SURGICAL VASER 2.1 LIPO SYSTEM | Sound Surgical Technologies, LLC | 2011-06-23 | 141 | 0 |
| K110255 | SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM | Sound Surgical Technologies, LLC | 2011-04-04 | 66 | 0 |
| K022051 | SOUNDVASER SYSTEM | Sound Surgical Technologies, LLC | 2002-09-11 | 79 | 2 |
| K993868 | THE SOUNDVASER DISSECTION SYSTEM | Sound Surgical Technologies, LLC | 1999-12-21 | 36 | 2 |
| K991791 | SOUND VASER SYSTEM | Sound Surgical Technologies, LLC | 1999-08-12 | 79 | 2 |
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