510(k) · Cleared
ClearedShiNeo Silicone Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shineo Technology Co., Ltd. · MIB Elastomer, Silicone Block
Cleared on Dec 23, 2022 as substantially equivalent to K193392 (Metalware Technology Corp., 2020) after a 102-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Dec 23, 2022
- Review
- 102 days
- Class
- Class II
- Product code
- MIB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K021820 (2002). No later device cites it as a predicate yet.
- Root · 3 generations backK021820 Aart Silicone Carving BlockAesthetic and Reconstructive Technologies, Inc. · 2002 · Recalled
- 2 generations backK171851 SoftxilBistool · 2018
- 1 generation backK193392 BioSiCar Silicone ImplantMetalware Technology Corp. · 2020
- This deviceK222748 ShiNeo Silicone ImplantShineo Technology Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K021820 | Aart Silicone Carving Block | Aesthetic and Reconstructive Technologies, Inc. | 2002 | 1 |
| −2 | K171851 | Softxil | Bistool | 2018 | — |
| −1 | K193392 | BioSiCar Silicone Implant | Metalware Technology Corp. | 2020 | — |
| 0 (this device) | K222748 | ShiNeo Silicone Implant | Shineo Technology Co., Ltd. | 2022 | — |
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 |
|---|---|---|---|
| * | K193392 | BioSiCar Silicone ImplantSummary page 5…pei City, 24262 Taiwan 2. Predicate Device(s) Proprietary/Trade name BioSiCar Silicone Implant K193392 Common or Usual Name: MIB Primary Product code: Additional Product code LZK, FWP Regulation Number:… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All MIB devicesMIB Elastomer, Silicone Block: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
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?
ShiNeo Silicone Implant is intended for the augmentation or reconstruction of the nasal and/or chin contour
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222748 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222748: ShiNeo Silicone Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222748
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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