510(k) · Cleared
ClearedMedisil Silicone Sheeting
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medisil Corporation · MIB Elastomer, Silicone Block
Cleared on Apr 1, 2004 after an 80-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Apr 1, 2004
- Review
- 80 days
- Class
- Class II
- Product code
- MIB
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK040042 Medisil Silicone SheetingMedisil Corporation · 2004
- Descendant · cites it directly · 4 of its ownK162624 Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. · 2017
- Descendant · 2 generations on · 3 of its ownK181387 Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. · 2019
- Descendant · 3 generations on · 1 of its ownK220760 Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK223051 Pre-Formed Silicone BlockInternational Medical Devices, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK200073 AugMENTA Penile ImplantAugmenta, LLC · 2022
Most influential descendants
Showing 5 of 5 · See all- K162624Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. · 2017 · cites it directly4descendants
- K181387Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. · 2019 · 2 generations on3descendants
- K220760Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. · 2022 · 3 generations on1descendant
- K223051Pre-Formed Silicone BlockInternational Medical Devices, Inc. · 2023 · 2 generations on0descendants
- K200073AugMENTA Penile ImplantAugmenta, LLC · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040042 | Medisil Silicone Sheeting | Medisil Corporation | 2004 | — |
| +1 | K162624 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | 2017 | — |
| +2 | K181387 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | 2019 | — |
| +3 | K220760 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | 2022 | — |
| +2 | K223051 | Pre-Formed Silicone Block | International Medical Devices, Inc. | 2023 | — |
| +3 | K200073 | AugMENTA Penile Implant | Augmenta, LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 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? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162624 | Pre-Formed Penile Silicone Block | 2017 | 4 |
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, K162624 (International Medical Devices, Inc., 2017) has gone furthest, with 4 descendants 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?
Sheeting is indicated for short term use for nasal splinting, wound dressings, scar coverings and temporary joint spacers.
For long term use, this device is indicated for tympanic membrane repair, dural covering, nasal septal repair, tendon anastamosis and neural repair, correction of strabismus, galea repair, orbital floor repair, hemodialysis shunt anchors, facilitation of osteogenesis, repair of urethral strictures, staged repair of omphalocoel and repair of orbital floor fractures.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K040042 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040042: Medisil Silicone Sheeting.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040042
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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