510(k) · Cleared
ClearedSilicone Elastomer Sheeting
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Specialty Surgical Products, Inc. · MIB Elastomer, Silicone Block
Cleared on Mar 13, 1998 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Mar 13, 1998
- Review
- 88 days
- Class
- Class II
- Product code
- MIB
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK974653 Silicone Elastomer SheetingSpecialty Surgical Products, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK033796 Kurz Silicone Strips, Models SF-1, SF-1W, SF-1 BSHeinz Kurz GmbH Medizintechnik · 2004
- Descendant · 2 generations on · 0 of its ownK260266 Tympendi™ (810)Grace Medical, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974653 | Silicone Elastomer Sheeting | Specialty Surgical Products, Inc. | 1998 | — |
| +1 | K033796 | Kurz Silicone Strips, Models SF-1, SF-1W, SF-1 BS | Heinz Kurz GmbH Medizintechnik | 2004 | — |
| +2 | K260266 | Tympendi™ (810) | Grace Medical, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MIB? 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 MIB device
- #1 K241150 MISTI Silicone Implantscore 8.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033796 | Kurz Silicone Strips, Models SF-1, SF-1W, SF-1 BS | 2004 | 1 |
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?
- Of its descendants, K033796 (Heinz Kurz GmbH Medizintechnik, 2004) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MIB devicesMIB Elastomer, Silicone Block: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MIB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MIB
102in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MIB
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MIB
18in 2025
MAUDE reports naming product code MIB, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 10 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 3 | 102 | 0 | 19 |
| 2023 | 1 | — | 0 | 74 |
| 2024 | 1 | — | 0 | 32 |
| 2025 | 0 | — | 3 | 18 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Specialty Surgical Products Silicone Sheeting is intended for a variety of medical purposes both in short term and long term applications. For short term application the indications for usc are: for nasal splinting, wound dressings, managment of hypertrophic or keloid scarring, to prevent soft tissue-fibrosis or bony ankylosis following surgical correction of trismus, temporary joint spacers and laboratory uses. For long-term application the indications…
Read the full statement (139 words)
Specialty Surgical Products Silicone Sheeting is intended for a variety of medical purposes both in short term and long term applications. For short term application the indications for usc are: for nasal splinting, wound dressings, managment of hypertrophic or keloid scarring, to prevent soft tissue-fibrosis or bony ankylosis following surgical correction of trismus, temporary joint spacers and laboratory uses. For long-term application the indications for use are: for nasal septal repair, orbital floor reconstruction, tympanic membrane repair, dialysis shunt anchoring, duramater repair, staged repair of omphalocele, for lengthening extraocular muscles in select cases of strabismus, as a protective sheathing to help facilitate neural regeneration and tendon anastomosis, as a protective sheathing to help facilitate osteogenesis, guided tissue regeneration between teeth and gingival margin, or external ear canal for example
Warning: Not for permanent use in Temporo Mandibular Joint applications.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974653 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974653: Silicone Elastomer Sheeting.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974653
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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