Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MIX — Predicate Candidate Screening
17 FDA 510(k) clearances under this product code; the 50 most recent screened below.
63 daysmedian FDA review time
248 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240919 | Silk Voice (SMI-04) | Sofregen Medical | 2024-05-03 | 30 | 0 |
| K180631 | Silk Voice | Sofregen Medical, Inc. | 2018-11-08 | 244 | 0 |
| K150400 | Renu Gel | Cytophil, Inc. | 2015-04-06 | 47 | 0 |
| K121795 | CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT | Cytophil, Inc. | 2013-02-22 | 248 | 0 |
| K083783 | VF LIQUIGEL | Coapt Systems, Inc. | 2009-09-11 | 266 | 0 |
| K081816 | VOCALIS AND VOCALIS SM | Cytophil, Inc. | 2009-01-05 | 193 | 0 |
| K081815 | VOCALIS GEL | Cytophil, Inc. | 2009-01-05 | 193 | 0 |
| K080956 | MODIFICATION TO VF GEL PLUS | Coapt Systems, Inc. | 2008-04-25 | 22 | 0 |
| K071663 | VF GEL PLUS | Coapt Systems, Inc. | 2008-02-15 | 242 | 0 |
| K070090 | RADIESSE LARYNGEAL IMPLANT | Bioform Medical, Inc. | 2007-03-01 | 50 | 0 |
| K060815 | JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT | Bioform Medical, Inc. | 2006-04-18 | 22 | 1 |
| K033398 | LARYNGEAL AUGMENTATION IMPLANT | Bioform, Inc. | 2003-12-12 | 49 | 0 |
| K011554 | LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT | Biomet, Inc. | 2001-06-26 | 39 | 0 |
| K001466 | VOCOM SILICONE SYSTEM | Smith & Nephew, Inc. | 2000-07-26 | 77 | 0 |
| K000533 | VOCOM IMPLANT- 8MM | Smith & Nephew, Inc. | 2000-03-01 | 13 | 0 |
| K983525 | GORE REVOX THYROPLASTY IMPLANT | W. L. Gore & Associates, Inc. | 1998-12-10 | 63 | 0 |
| K972317 | MONTGOMERY THYROPLASTY IMPLANT SYSTEM | Boston Medical Products, Inc. | 1997-09-18 | 90 | 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