510(k) · Cleared
ClearedModification to VF Gel Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coapt Systems, Inc. · MIX System, Vocal Cord Medialization
Cleared on Apr 25, 2008 as substantially equivalent to K071663 (Coapt Systems, Inc., 2008) after a 22-day review. Its family tree reaches back 7 generations to 1992. 3 later devices descend from it.
- Decided
- Apr 25, 2008
- Review
- 22 days
- Class
- Class II
- Product code
- MIX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K913882 (1992). 25 ancestors in all, the oldest K852682 (1985). 3 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK913882 Zara Silicone BlockByron Medical · 1992
- 6 generations backK970910 Xomed Silicone Block/StripXomed, Inc. · 1997
- 5 generations backK972317 Montgomery Thyroplasty Implant SystemBoston Medical Products, Inc. · 1997
- 4 generations backK982294 Xomed Silicone Pre-Form BlocksXomed, Inc. · 1998
- 3 generations backK013243 Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models…Bioform, Inc. · 2002 · Recalled
- 2 generations backK033398 Laryngeal Augmentation ImplantBioform, Inc. · 2003
- 1 generation backK071663 VF Gel PlusCoapt Systems, Inc. · 2008
- This deviceK080956 Modification to VF Gel PlusCoapt Systems, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK083783 VF LiquigelCoapt Systems, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK081816 Vocalis and Vocalis SMCytophil, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK081815 Vocalis GelCytophil, Inc. · 2009
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913882 | Zara Silicone Block | Byron Medical | 1992 | — |
| −6 | K970910 | Xomed Silicone Block/Strip | Xomed, Inc. | 1997 | — |
| −5 | K972317 | Montgomery Thyroplasty Implant System | Boston Medical Products, Inc. | 1997 | — |
| −4 | K982294 | Xomed Silicone Pre-Form Blocks | Xomed, Inc. | 1998 | — |
| −3 | K013243 | Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1 | Bioform, Inc. | 2002 | 1 |
| −2 | K033398 | Laryngeal Augmentation Implant | Bioform, Inc. | 2003 | — |
| −1 | K071663 | VF Gel Plus | Coapt Systems, Inc. | 2008 | — |
| 0 (this device) | K080956 | Modification to VF Gel Plus | Coapt Systems, Inc. | 2008 | — |
| +1 | K083783 | VF Liquigel | Coapt Systems, Inc. | 2009 | — |
| +1 | K081816 | Vocalis and Vocalis SM | Cytophil, Inc. | 2009 | — |
| +1 | K081815 | Vocalis Gel | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 3 | 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? (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 |
|---|---|---|---|
| * | K071663 | VF Gel PlusSummary page 2…Number VF Gel Plus MIX Coapt Systems K071663 DEVICE DESCRIPTION Sterile, latex free, non-pyrogenic, highly thixotropic, high yield strength clear gel with a neutral pH. The… | 2008 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 25 ancestors has a recall of any class.
- Of its descendants, K083783 (Coapt Systems, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K071663.
How does its category compare?
All MIX devicesMIX System, Vocal Cord Medialization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
The VF Gel is indicated for vocal fold medialization in the treatment of vocal fold insufficiency, where insufficiency may be improved by injection of a soft tissue bulking agent. VF Gel injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved glottal closure. Improved glottal closure may allow improved phonation, improvement of cough, and an improved ability to protect the airway during swallowing. VF Gel is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080956 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080956: Modification to VF Gel Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080956
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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