510(k) · Cleared
ClearedXomed Silicone Pre-Form Blocks
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xomed, Inc. · KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Cleared on Sep 18, 1998 as substantially equivalent to K970910 (Xomed, Inc., 1997) and 1 other predicate after an 80-day review. Its family tree reaches back 3 generations to 1992. 12 later devices descend from it.
- Decided
- Sep 18, 1998
- Review
- 80 days
- Class
- Class II
- Product code
- KHJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K913882 (1992). 7 ancestors in all. 12 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK913882 Zara Silicone BlockByron Medical · 1992
- 2 generations backK970910 Xomed Silicone Block/StripXomed, Inc. · 1997
- 1 generation backK972317 Montgomery Thyroplasty Implant SystemBoston Medical Products, Inc. · 1997
- This deviceK982294 Xomed Silicone Pre-Form BlocksXomed, Inc. · 1998
- Descendant · cites it directly · 11 of its ownK013243 Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models…Bioform, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 10 of its ownK033398 Laryngeal Augmentation ImplantBioform, Inc. · 2003
- Descendant · 3 generations on · 6 of its ownK060815 Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 5 of its ownK070090 Radiesse Laryngeal ImplantBioform Medical, Inc. · 2007
- Descendant · 3 generations on · 4 of its ownK071663 VF Gel PlusCoapt Systems, Inc. · 2008
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K013243Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1Bioform, Inc. · 2002 · cites it directly11descendants
- K033398Laryngeal Augmentation ImplantBioform, Inc. · 2003 · 2 generations on10descendants
- K060815Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc. · 2006 · 3 generations on6descendants
- K070090Radiesse Laryngeal ImplantBioform Medical, Inc. · 2007 · 2 generations on5descendants
- K071663VF Gel PlusCoapt Systems, Inc. · 2008 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913882 | Zara Silicone Block | Byron Medical | 1992 | — |
| −2 | K970910 | Xomed Silicone Block/Strip | Xomed, Inc. | 1997 | — |
| −1 | K972317 | Montgomery Thyroplasty Implant System | Boston Medical Products, Inc. | 1997 | — |
| 0 (this device) | K982294 | Xomed Silicone Pre-Form Blocks | Xomed, Inc. | 1998 | — |
| +1 | 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 | — |
| +3 | K060815 | Juliesse Injectable Laryngeal Augmentation Implant | Bioform Medical, Inc. | 2006 | 1 |
| +2 | K070090 | Radiesse Laryngeal Implant | Bioform Medical, Inc. | 2007 | — |
| +3 | K071663 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K970910 | Xomed Silicone Block/StripSummary page 1…e for vocal fold medialization and augmentation. 7.0 Substantial Equivalence Xomed markets both silicone blocks and strips for implant uses in head and neck surgery by K970910. The Silicone Pre-form Blocks are substantially equivalent to these predicate products in that they are made from the same materi… | 1997 |
| * | K972317 | Montgomery Thyroplasty Implant SystemSummary page 1…ility approval for implant applications. Additionally, the Silicone elastomer Pre-form Blocks are similar to the Montgomery Thyroplasty Implants, Boston Medical Products K972317 for the intended use in thyroplasty procedures involving medialization and augmentation of the vocal fold. The difference is the… | 1997 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013243 | Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1 | 2002 | 11 |
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 6 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K013243 (Bioform, Inc., 2002) has gone furthest, with 11 descendants of its own.
- 1 other device also cites its predicate K970910.
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?
The Silicone Pre-form Blocks are indicated as an implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures 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/K982294 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982294: Xomed Silicone Pre-Form Blocks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982294
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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