510(k) · Cleared
ClearedXomed Silicone Block/Strip
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 May 2, 1997 as substantially equivalent to K953013 (Merocel Corp., 1995) and 1 other predicate after a 51-day review. Its family tree reaches back 1 generation to 1992. 15 later devices descend from it.
- Decided
- May 2, 1997
- Review
- 51 days
- Class
- Class II
- Product code
- KHJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K913882 (1992). 2 ancestors in all. 15 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK913882 Zara Silicone BlockByron Medical · 1992
- This deviceK970910 Xomed Silicone Block/StripXomed, Inc. · 1997
- Descendant · cites it directly · 14 of its ownK972317 Montgomery Thyroplasty Implant SystemBoston Medical Products, Inc. · 1997
- Descendant · cites it directly · 12 of its ownK982294 Xomed Silicone Pre-Form BlocksXomed, Inc. · 1998
- Descendant · 2 generations on · 11 of its ownK013243 Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models…Bioform, Inc. · 2002 · Recalled
- Descendant · 3 generations on · 10 of its ownK033398 Laryngeal Augmentation ImplantBioform, Inc. · 2003
- Descendant · 4 generations on · 6 of its ownK060815 Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc. · 2006 · Recalled
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K972317Montgomery Thyroplasty Implant SystemBoston Medical Products, Inc. · 1997 · cites it directly14descendants
- K982294Xomed Silicone Pre-Form BlocksXomed, Inc. · 1998 · cites it directly12descendants
- K013243Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1Bioform, Inc. · 2002 · 2 generations on11descendants
- K033398Laryngeal Augmentation ImplantBioform, Inc. · 2003 · 3 generations on10descendants
- K060815Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc. · 2006 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913882 | Zara Silicone Block | Byron Medical | 1992 | — |
| 0 (this device) | K970910 | Xomed Silicone Block/Strip | Xomed, Inc. | 1997 | — |
| +1 | K972317 | Montgomery Thyroplasty Implant System | Boston Medical Products, Inc. | 1997 | — |
| +1 | 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 |
| +3 | K033398 | Laryngeal Augmentation Implant | Bioform, Inc. | 2003 | — |
| +4 | K060815 | Juliesse Injectable Laryngeal Augmentation Implant | Bioform Medical, Inc. | 2006 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 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? (6)
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 |
|---|---|---|---|
| * | K953013 | Merocel Reinforced Silicone SheetsSummary page 1…Both silicone sheeting and silicone block were marketed by Xomed prior to May 16, 1976. A reinforced version of the Silicone Sheeting was introduced in 1995 via 510(k) [K953013]. The Silicone Block and Strip proposed in this submission are substantially equivalent to these predicate products in that they… | 1995 |
| * | K913882 | Zara Silicone BlockSummary page 1…e from essentially the same base material. Additionally, the proposed devices are similar to predicate products from other manufacturers, i.e. Implantech Silicone Block (K913882), Dow Silicone Block and McGhan Silicone Block (510k unknown). Again, the intended use and base materials are essentially identic… | 1992 |
| * | — | Xomed Silicone Sheeting Named without a submission number | |
| * | — | Xomed Silicone Block Named without a submission number | |
| * | — | Dow Silicone Block Named without a submission number | |
| * | — | McGhan Silicone Block Named without a submission number |
What descends from it? (15)
See all 152 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K972317 (Boston Medical Products, Inc., 1997) has gone furthest, with 14 descendants of its own.
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 Blocks/Strips are intended for use as an implant material to aid in surgical repairs in various otorhinolaryngological surgical procedures and space occupying augmentation in reconstructive Head & Neck surgery.
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/K970910 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970910: Xomed Silicone Block/Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970910
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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