510(k) · Cleared
ClearedSilk Voice (SMI-04)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sofregen Medical · MIX System, Vocal Cord Medialization
Cleared on May 3, 2024 as substantially equivalent to K180631 (Sofregen Medical, Inc., 2018) after a 30-day review. Its family tree reaches back 9 generations to 1992.
- Decided
- May 3, 2024
- Review
- 30 days
- Class
- Class II
- Product code
- MIX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K913882 (1992). 27 ancestors in all, the oldest K852682 (1985). No later device cites it as a predicate yet.
- Root · 9 generations backK913882 Zara Silicone BlockByron Medical · 1992
- 5 generations between
- 3 generations backK060815 Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc. · 2006 · Recalled
- 2 generations backK070090 Radiesse Laryngeal ImplantBioform Medical, Inc. · 2007
- 1 generation backK180631 Silk VoiceSofregen Medical, Inc. · 2018
- This deviceK240919 Silk Voice (SMI-04)Sofregen Medical · 2024
Show all 9 generations
- Root · 9 generations backK913882 Zara Silicone BlockByron Medical · 1992
- 8 generations backK970910 Xomed Silicone Block/StripXomed, Inc. · 1997
- 7 generations backK972317 Montgomery Thyroplasty Implant SystemBoston Medical Products, Inc. · 1997
- 6 generations backK982294 Xomed Silicone Pre-Form BlocksXomed, Inc. · 1998
- 5 generations backK013243 Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models…Bioform, Inc. · 2002 · Recalled
- 4 generations backK033398 Laryngeal Augmentation ImplantBioform, Inc. · 2003
- 3 generations backK060815 Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc. · 2006 · Recalled
- 2 generations backK070090 Radiesse Laryngeal ImplantBioform Medical, Inc. · 2007
- 1 generation backK180631 Silk VoiceSofregen Medical, Inc. · 2018
- This deviceK240919 Silk Voice (SMI-04)Sofregen Medical · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K913882 | Zara Silicone Block | Byron Medical | 1992 | — |
| −8 | K970910 | Xomed Silicone Block/Strip | Xomed, Inc. | 1997 | — |
| −7 | K972317 | Montgomery Thyroplasty Implant System | Boston Medical Products, Inc. | 1997 | — |
| −6 | K982294 | Xomed Silicone Pre-Form Blocks | Xomed, Inc. | 1998 | — |
| −5 | K013243 | Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1 | Bioform, Inc. | 2002 | 1 |
| −4 | K033398 | Laryngeal Augmentation Implant | Bioform, Inc. | 2003 | — |
| −3 | K060815 | Juliesse Injectable Laryngeal Augmentation Implant | Bioform Medical, Inc. | 2006 | 1 |
| −2 | K070090 | Radiesse Laryngeal Implant | Bioform Medical, Inc. | 2007 | — |
| −1 | K180631 | Silk Voice | Sofregen Medical, Inc. | 2018 | — |
| 0 (this device) | K240919 | Silk Voice (SMI-04) | Sofregen Medical | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 3 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MIX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K180631 | Silk VoiceSummary page 4…n Regulation: 21 CFR 874.3620 Regulatory Class: II Product Code: MIX Panel: Ear, Nose, and Throat 3. PREDICATE DEVICE Predicate Device: Sofregen’s Silk Voice (K180631) 4. DEVICE DESCRIPTION Silk Voice® is a sterile, non-pyrogenic, cohesive implant provided in a prefilled syringe and i… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 27 ancestors have a recall of any class.
How does its category compare?
All MIX devicesMIX System, Vocal Cord Medialization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MIX
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MIX
193in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MIX
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MIX
2in 2024
MAUDE reports naming product code MIX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 3 | 193 | 0 | 2 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 1 | — | 1 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 10 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Silk Voice® is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Silk Voice® injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved phonation. Vocal fold insufficiency associated with serious aspiration difficulties may be an urgent indication.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240919 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240919: Silk Voice (SMI-04).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240919
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026