Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aesthetic and Reconstructive Technologies, Inc. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
86 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023678 | DIMISIL SCAR GEL | Aesthetic and Reconstructive Technologies, Inc. | 2003-01-23 | 83 | 0 |
| K022306 | AART SILICONE TUBING | Aesthetic and Reconstructive Technologies, Inc. | 2002-10-10 | 86 | 0 |
| K022511 | AART CALF IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | 2002-08-26 | 27 | 1 |
| K022223 | AART SILICONE SHEETING | Aesthetic and Reconstructive Technologies, Inc. | 2002-08-08 | 30 | 0 |
| K021820 | AART SILICONE CARVING BLOCK | Aesthetic and Reconstructive Technologies, Inc. | 2002-07-16 | 42 | 1 |
| K021839 | AART GLUTEAL IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | 2002-07-16 | 42 | 1 |
| K021337 | AART PECTORALIS IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | 2002-07-03 | 68 | 1 |
| K021419 | AART MALAR IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | 2002-07-02 | 60 | 1 |
| K021418 | AART NASAL IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | 2002-07-02 | 60 | 0 |
| K021417 | AART CHIN IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | 2002-07-02 | 60 | 1 |
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