Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
MIC · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
73 daysmedian FDA review time
165 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K021337 | AART PECTORALIS IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | 2002-07-03 | 68 | 1 |
| K002633 | SILMAX PECTORAL IMPLANT | Pillar Surgical, Inc. | 2000-11-21 | 90 | 0 |
| K982762 | SEARE BIOMEDICAL PECTORALIS IMPLANT | Seare Biomedical Corp. | 1998-09-30 | 55 | 0 |
| K983043 | SEARE BIOMEDICAL SILICONE BLOCK | Seare Biomedical Corp. | 1998-09-30 | 30 | 0 |
| K973729 | POWERFLEX PEC IMPLANT | Hanson Medical, Inc. | 1997-12-24 | 85 | 0 |
| K961072 | PEC IMPLANT | Rand Scientific Corp. | 1996-04-19 | 32 | 0 |
| K944163 | SPECTRUM DISIGNS PECTORAL IMPLANT | Spectrum Designs, Inc. | 1994-11-07 | 73 | 0 |
| K913768 | PEC IMPLANT | Applied Biomaterial Technologies | 1992-02-03 | 165 | 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