510(k) · Cleared
ClearedAart Silicone Sheeting
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesthetic and Reconstructive Technologies, Inc. · MIB Elastomer, Silicone Block
Cleared on Aug 8, 2002 after a 30-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Aug 8, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- MIB
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK022223 Aart Silicone SheetingAesthetic and Reconstructive Technologies, Inc. · 2002
- 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
- Descendant · cites it directly · 0 of its ownK071823 Perma Facial ImplantsSurgisil · 2007
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022223 | Aart Silicone Sheeting | Aesthetic and Reconstructive Technologies, Inc. | 2002 | — |
| +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 | — |
| +1 | K071823 | Perma Facial Implants | Surgisil | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2026 | 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 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? (1)
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 |
|---|---|---|---|
| * | — | Seare Biomedical Silicone Sheeting Named without a submission number |
What descends from it? (3)
2 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?
- 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?
The AART Silicone Sheeting has a variety of intmded uses. The Silicone sh- is intended for short term and long term applications. Short tenn indications for use: Nasal splmtmg Wound dressing Management of keloid or hypertrophic scarring TemporaryuseinTMJdiseas® Tempomyjoint shims Laboratory-uses Long term indications for use: Nasal septal repair Orbital floor reconstnrclion Tympanic membrane repair Dialysis shrmt d o l j n g Duramekr repair Staged repair…
Read the full statement (119 words)
The AART Silicone Sheeting has a variety of intmded uses. The Silicone sh- is intended for short term and long term applications.
Short tenn indications for use:
Nasal splmtmg
Wound dressing
Management of keloid or hypertrophic scarring
TemporaryuseinTMJdiseas®
Tempomyjoint shims
Laboratory-uses
Long term indications for use:
Nasal septal repair
Orbital floor reconstnrclion
Tympanic membrane repair
Dialysis shrmt d o l j n g
Duramekr repair
Staged repair of omphalocoel
hgthenkgofext~aocularmuscles
As a protective sheathing to help facilitateneural regmerztion and tendon anastomosis
As a protective sheatlungto help facilitate osteogenesis
Other uses deemed appropriate by the using surgeon
Caution: The American Academy of Oral Maxillofacial Surgeons recomniends against the use of silicone products for permanent treatmeat of Temporo Mapctibular Joint Disease.
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/K022223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022223: Aart Silicone Sheeting.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022223
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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