510(k) · Cleared
Recalled · Class II · 2015Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioform, Inc. · KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Cleared on Jan 9, 2002 as substantially equivalent to K974311 (Gyrus Ent LLC, 1998) and 2 other predicates after a 103-day review. Its family tree reaches back 4 generations to 1992. 11 later devices descend from it. It has been recalled once.
- Decided
- Jan 9, 2002
- Review
- 103 days
- Class
- Class II
- Product code
- KHJ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K913882 (1992). 10 ancestors in all. 11 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK913882 Zara Silicone BlockByron Medical · 1992
- 3 generations backK970910 Xomed Silicone Block/StripXomed, Inc. · 1997
- 2 generations backK972317 Montgomery Thyroplasty Implant SystemBoston Medical Products, Inc. · 1997
- 1 generation backK982294 Xomed Silicone Pre-Form BlocksXomed, Inc. · 1998
- This deviceK013243 Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models…Bioform, Inc. · 2002
- Descendant · cites it directly · 10 of its ownK033398 Laryngeal Augmentation ImplantBioform, Inc. · 2003
- Descendant · 2 generations on · 6 of its ownK060815 Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc. · 2006 · Recalled
- Descendant · cites it directly · 5 of its ownK070090 Radiesse Laryngeal ImplantBioform Medical, Inc. · 2007
- Descendant · 2 generations on · 4 of its ownK071663 VF Gel PlusCoapt Systems, Inc. · 2008
- Descendant · 3 generations on · 3 of its ownK080956 Modification to VF Gel PlusCoapt Systems, Inc. · 2008
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K033398Laryngeal Augmentation ImplantBioform, Inc. · 2003 · cites it directly10descendants
- K060815Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc. · 2006 · 2 generations on6descendants
- K070090Radiesse Laryngeal ImplantBioform Medical, Inc. · 2007 · cites it directly5descendants
- K071663VF Gel PlusCoapt Systems, Inc. · 2008 · 2 generations on4descendants
- K080956Modification to VF Gel PlusCoapt Systems, Inc. · 2008 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913882 | Zara Silicone Block | Byron Medical | 1992 | — |
| −3 | K970910 | Xomed Silicone Block/Strip | Xomed, Inc. | 1997 | — |
| −2 | K972317 | Montgomery Thyroplasty Implant System | Boston Medical Products, Inc. | 1997 | — |
| −1 | K982294 | Xomed Silicone Pre-Form Blocks | Xomed, Inc. | 1998 | — |
| 0 (this device) | K013243 | Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1 | Bioform, Inc. | 2002 | — |
| +1 | 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 | — |
| +2 | K071663 | VF Gel Plus | Coapt Systems, Inc. | 2008 | — |
| +3 | K080956 | Modification to VF Gel Plus | Coapt Systems, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 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 KHJ? 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 KHJ device
- #1 K260266 Tympendi™ (810)score 12.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K974311 | Vocom (Vocal Cord Medialization) ImplantSummary page 2…aptite™ 43 SUBSTANTIAL EQUIVALENCE The Coaptite™ Laryngeal Augmentation System is substantially equivalent to the Smith & Nephew VoCoM Vocal Cord Medialization System (K974311; Gore ReVox Thyroplasty Implant (K983525); and Xomed Silicone Pre-form Blocks (K982294). All of the predicate devices have the sa… | 1998 |
| * | K983525 | Gore Revox Thyroplasty ImplantSummary page 2…Coaptite™ Laryngeal Augmentation System is substantially equivalent to the Smith & Nephew VoCoM Vocal Cord Medialization System (K974311; Gore ReVox Thyroplasty Implant (K983525); and Xomed Silicone Pre-form Blocks (K982294). All of the predicate devices have the same intended use as a space-occupying mate… | 1998 |
| * | K982294 | Xomed Silicone Pre-Form BlocksSummary page 2…stantially equivalent to the Smith & Nephew VoCoM Vocal Cord Medialization System (K974311; Gore ReVox Thyroplasty Implant (K983525); and Xomed Silicone Pre-form Blocks (K982294). All of the predicate devices have the same intended use as a space-occupying material for vocal fold medialization and augmenta… | 1998 |
What descends from it? (11)
See all 114 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 26, 2015 | Class II | Z-0368-2016 | Other | The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K033398 (Bioform, Inc., 2003) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K974311.
How does its category compare?
All KHJ devicesKHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KHJ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KHJ
46in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KHJ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KHJ
1in 2025
MAUDE reports naming product code KHJ, 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 | 3 | 46 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 1 | — | 1 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 1 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Coaptite™ is intended as an injectable, space-occupying implant for vocal fold medialization and augmentation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013243 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013243: Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013243
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026