FDA product code MIX: System, Vocal Cord Medialization
MIX is the FDA product code for system, vocal cord medialization. It is a Class II device, regulated under 21 CFR 874.3620 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 17 510(k) submissions under MIX, 1 in the last five years, from 10 different applicants. The average 510(k) review took 111 days (median 63); 30 days on average over the last three years. FDA has posted 1 recall for MIX devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Vocal Cord Medialization |
| Device class | Class II |
| Regulation | 21 CFR 874.3620 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for MIX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 244 |
| 2024 | 1 | 30 |
Compare with all 510(k) review times · Search every MIX clearance
Top MIX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cytophil, Inc. | 4 | 2015-04-06 |
| Coapt Systems, Inc. | 3 | 2009-09-11 |
| Bioform Medical, Inc. | 2 | 2007-03-01 |
| Smith & Nephew, Inc. | 2 | 2000-07-26 |
| Sofregen Medical | 1 | 2024-05-03 |
5 more applicants have MIX clearances. See the full list in Caduvo.
Most recent MIX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240919 | Sofregen Medical | Silk Voice (SMI-04) | 2024-05-03 | 30 |
| K180631 | Sofregen Medical, Inc. | Silk Voice | 2018-11-08 | 244 |
| K150400 | Cytophil, Inc. | Renu Gel | 2015-04-06 | 47 |
| K121795 | Cytophil, Inc. | CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT | 2013-02-22 | 248 |
| K083783 | Coapt Systems, Inc. | VF LIQUIGEL | 2009-09-11 | 266 |
Recalls for MIX devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-10-26.
Frequently asked questions
What is FDA product code MIX?
MIX is the FDA product code for system, vocal cord medialization. It is a Class II device, regulated under 21 CFR 874.3620 and reviewed by the Ear, Nose and Throat panel.
What device class is MIX?
Class II, regulation 21 CFR 874.3620. Typical premarket route: 510(k).
How long does a 510(k) take for product code MIX?
Across 17 cleared submissions the average was 111 days from receipt to decision (median 63).
Which companies have the most MIX clearances?
Cytophil, Inc. (4); Coapt Systems, Inc. (3); Bioform Medical, Inc. (2); Smith & Nephew, Inc. (2); Sofregen Medical (1).
Have MIX devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-10-26.
Next steps
- Run an FDA pathway report with predicate devices for product code MIX
- Run a recall and safety report across every MIX manufacturer
- Watch product code MIX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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