510(k) · Cleared
ClearedVF 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 Feb 15, 2008 as substantially equivalent to K033398 (Bioform, Inc., 2003) after a 242-day review. Its family tree reaches back 6 generations to 1992. 4 later devices descend from it.
- Decided
- Feb 15, 2008
- Review
- 242 days
- Class
- Class II
- Product code
- MIX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K913882 (1992). 24 ancestors in all, the oldest K852682 (1985). 4 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK913882 Zara Silicone BlockByron Medical · 1992
- 5 generations backK970910 Xomed Silicone Block/StripXomed, Inc. · 1997
- 4 generations backK972317 Montgomery Thyroplasty Implant SystemBoston Medical Products, Inc. · 1997
- 3 generations backK982294 Xomed Silicone Pre-Form BlocksXomed, Inc. · 1998
- 2 generations backK013243 Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models…Bioform, Inc. · 2002 · Recalled
- 1 generation backK033398 Laryngeal Augmentation ImplantBioform, Inc. · 2003
- This deviceK071663 VF Gel PlusCoapt Systems, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK080956 Modification to VF Gel PlusCoapt Systems, Inc. · 2008
- Descendant · 2 generations on · 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 4 of 4 · See all- K080956Modification to VF Gel PlusCoapt Systems, Inc. · 2008 · cites it directly3descendants
- K083783VF LiquigelCoapt Systems, Inc. · 2009 · 2 generations on0descendants
- K081816Vocalis and Vocalis SMCytophil, Inc. · 2009 · cites it directly0descendants
- K081815Vocalis GelCytophil, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913882 | Zara Silicone Block | Byron Medical | 1992 | — |
| −5 | K970910 | Xomed Silicone Block/Strip | Xomed, Inc. | 1997 | — |
| −4 | K972317 | Montgomery Thyroplasty Implant System | Boston Medical Products, Inc. | 1997 | — |
| −3 | K982294 | Xomed Silicone Pre-Form Blocks | Xomed, Inc. | 1998 | — |
| −2 | K013243 | Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1 | Bioform, Inc. | 2002 | 1 |
| −1 | K033398 | Laryngeal Augmentation Implant | Bioform, Inc. | 2003 | — |
| 0 (this device) | K071663 | VF Gel Plus | Coapt Systems, Inc. | 2008 | — |
| +1 | K080956 | Modification to VF Gel Plus | Coapt Systems, Inc. | 2008 | — |
| +2 | 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 |
|---|---|---|
| 2008 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K033398 | Laryngeal Augmentation ImplantSummary page 1…0(k) or PMA Number Radiesse Injectable Laryngeal MIX Bioform Medical K033398 Medialization Implant DEVICE DESCRIPTION Sterile, latex free, non-pyrogenic, semi-solid, cohesive subdermal impla… | 2003 |
What descends from it? (4)
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 3.3 years on median.
- 1 of the 24 ancestors has a recall of any class.
- Of its descendants, K080956 (Coapt Systems, Inc., 2008) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K033398.
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 Plus 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. VT Gel Plus 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 Plus 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/K071663 · printed Nov 3, 2026
Cite this page
510(k) Report. “K071663: VF Gel Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K071663
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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