Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aesthetech Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
49 daysmedian FDA review time
58 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K873940 | CREAT BRAND O-RISE GENERAL ASPIRATOR | Aesthetech Corp. | 1987-11-25 | 58 | 0 |
| K873434 | CREAT BRAND MALAR IMPLANT | Aesthetech Corp. | 1987-09-11 | 16 | 0 |
| K853189 | CREAT BRAND I/A PACK CREAT BRAND PHACO PACK | Aesthetech Corp. | 1985-09-24 | 56 | 0 |
| K843678 | CREAT BRAND SKIN EXPANDER | Aesthetech Corp. | 1984-11-06 | 49 | 0 |
| K841283 | DISPOSABLE SUCTION TUBING SET | Aesthetech Corp. | 1984-04-24 | 27 | 0 |
| K812210 | CREAT BRAND WAGNER CHIN IMPLANT | Aesthetech Corp. | 1981-09-11 | 38 | 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