510(k) · Cleared
ClearedSoftxil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bistool · MIB Elastomer, Silicone Block
Cleared on Mar 16, 2018 as substantially equivalent to K021820 (Aesthetic and Reconstructive Technologies, Inc., 2002) after a 268-day review. Its family tree reaches back 1 generation to 2002. 3 later devices descend from it.
- Decided
- Mar 16, 2018
- Review
- 268 days
- Class
- Class II
- Product code
- MIB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021820 (2002). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK021820 Aart Silicone Carving BlockAesthetic and Reconstructive Technologies, Inc. · 2002 · Recalled
- This deviceK171851 SoftxilBistool · 2018
- Descendant · cites it directly · 1 of its ownK193392 BioSiCar Silicone ImplantMetalware Technology Corp. · 2020
- Descendant · cites it directly · 0 of its ownK241150 MISTI Silicone ImplantKeosan Trading Co. · 2024
- Descendant · 2 generations on · 0 of its ownK222748 ShiNeo Silicone ImplantShineo Technology Co., Ltd. · 2022
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 |
|---|---|---|---|---|---|
| −1 | K021820 | Aart Silicone Carving Block | Aesthetic and Reconstructive Technologies, Inc. | 2002 | 1 |
| 0 (this device) | K171851 | Softxil | Bistool | 2018 | — |
| +1 | K193392 | BioSiCar Silicone Implant | Metalware Technology Corp. | 2020 | — |
| +1 | K241150 | MISTI Silicone Implant | Keosan Trading Co. | 2024 | — |
| +2 | K222748 | ShiNeo Silicone Implant | Shineo Technology Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 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 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 |
|---|---|---|---|
| * | K021820 | Aart Silicone Carving BlockSummary page 5…Additional product codes: LZK, FWP 4. Predicate Device AART Silicone Carving Block by Aesthetic and Reconstructive Technologies, Inc. (AART) (K021820) 5. Device Description SOFTXIL is injection molded silicone implants used in facial surgery as nasal, paranasal, and chin… | 2002 |
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?
How does its category compare?
All MIB devicesMIB Elastomer, Silicone Block: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
SOFTXIL is intended for the augmentation or reconstruction of the nasal, malar, and or chin contour.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171851: Softxil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171851
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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