510(k) · Cleared
ClearedVocalis and Vocalis SM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cytophil, Inc. · MIX System, Vocal Cord Medialization
Cleared on Jan 5, 2009 as substantially equivalent to K013243 (Bioform, Inc., 2002) and 3 other predicates after a 193-day review. Its family tree reaches back 8 generations to 1992.
- Decided
- Jan 5, 2009
- Review
- 193 days
- Class
- Class II
- Product code
- MIX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K913882 (1992). 28 ancestors in all, the oldest K852682 (1985). No later device cites it as a predicate yet.
- Root · 8 generations backK913882 Zara Silicone BlockByron Medical · 1992
- 7 generations backK970910 Xomed Silicone Block/StripXomed, Inc. · 1997
- 6 generations backK972317 Montgomery Thyroplasty Implant SystemBoston Medical Products, Inc. · 1997
- 5 generations backK982294 Xomed Silicone Pre-Form BlocksXomed, Inc. · 1998
- 4 generations backK013243 Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models…Bioform, Inc. · 2002 · Recalled
- 3 generations backK033398 Laryngeal Augmentation ImplantBioform, Inc. · 2003
- 2 generations backK060815 Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc. · 2006 · Recalled
- 1 generation backK070090 Radiesse Laryngeal ImplantBioform Medical, Inc. · 2007
- This deviceK081816 Vocalis and Vocalis SMCytophil, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K913882 | Zara Silicone Block | Byron Medical | 1992 | — |
| −7 | K970910 | Xomed Silicone Block/Strip | Xomed, Inc. | 1997 | — |
| −6 | K972317 | Montgomery Thyroplasty Implant System | Boston Medical Products, Inc. | 1997 | — |
| −5 | K982294 | Xomed Silicone Pre-Form Blocks | Xomed, Inc. | 1998 | — |
| −4 | K013243 | Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1 | Bioform, Inc. | 2002 | 1 |
| −3 | K033398 | Laryngeal Augmentation Implant | Bioform, Inc. | 2003 | — |
| −2 | K060815 | Juliesse Injectable Laryngeal Augmentation Implant | Bioform Medical, Inc. | 2006 | 1 |
| −1 | K070090 | Radiesse Laryngeal Implant | Bioform Medical, Inc. | 2007 | — |
| 0 (this device) | K081816 | Vocalis and Vocalis SM | Cytophil, Inc. | 2009 | — |
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 |
| 2008 | 2 | 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.
Top candidate predicates for a new MIX device
- #1 K240919 Silk Voice (SMI-04)score 9.7 · 9 generations · no Class I recall
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K013243 | Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1Summary page 2…2 === 4.3 Substantial Equivalence The following are the predicate devices that are substantially equivalent to Vocalis and Vocalis SM: K013243 Coaptite Laryngeal Augmentation System BioForm Medical, Inc. 4133 Courtney Road, Suite 10 Franksv… | 2002 |
| * | K070090 | Radiesse Laryngeal ImplantSummary page 2…K013243 Coaptite Laryngeal Augmentation System BioForm Medical, Inc. 4133 Courtney Road, Suite 10 Franksville, WI 53126 K070090 Radiesse Laryngeal Implant BioForm Medical, Inc. 1875 South Grant St., Suite 110 San Mateo, CA 94… | 2007 |
| * | K071663 | VF Gel PlusSummary page 2…e, WI 53126 K070090 Radiesse Laryngeal Implant BioForm Medical, Inc. 1875 South Grant St., Suite 110 San Mateo, CA 94402 K071663 VF Long Term Coapt Systems, Inc. 1820 Embarcadero Rd. Palo Alto, CA 94303 K080956 Modi… | 2008 |
| * | K080956 | Modification to VF Gel PlusSummary page 2…St., Suite 110 San Mateo, CA 94402 K071663 VF Long Term Coapt Systems, Inc. 1820 Embarcadero Rd. Palo Alto, CA 94303 K080956 Modification to VF Gel Coapt Systems, Inc. 1820 Embarcadero Rd. Palo Alto, CA 94303 4.4 Bioc… | 2008 |
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 17 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 28 ancestors have a recall of any class.
- 3 other devices also cite its predicate K013243.
How does its category compare?
All MIX devicesMIX System, Vocal Cord Medialization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Vocalis and Vocalis SM are indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Vocalis 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. The product is intended to be durable for a period of one month.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081816 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081816: Vocalis and Vocalis SM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081816
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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