Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Andrew Technologies, LLC — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130152 | HYDRASOLVE LIPOPLASTY SYSTEM | Andrew Technologies, LLC | 2013-04-18 | 86 | 0 |
| K121218 | HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4 | Andrew Technologies, LLC | 2012-12-13 | 234 | 0 |
| K092066 | PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DI | Andrew Technologies, LLC | 2010-04-12 | 278 | 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