510(k) · Cleared
ClearedMINT Product Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hans Biomed Corporation · NEW Suture, Surgical, Absorbable, Polydioxanone
Cleared on Sep 9, 2020 as substantially equivalent to K163676 (Silhouette Lift, Inc., 2017) after a 371-day review. Its family tree reaches back 2 generations to 2015. 4 later devices descend from it.
- Decided
- Sep 9, 2020
- Review
- 371 days
- Class
- Class II
- Product code
- NEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K142061 (2015). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK142061 Silhouette InstaliftSilhouette Lift, Inc. · 2015
- 1 generation backK163676 Silhouette InstaLiftSilhouette Lift, Inc. · 2017
- This deviceK192423 MINT Product FamilyHans Biomed Corporation · 2020
- Descendant · cites it directly · 2 of its ownK220549 MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures)…Hans Biomed Corporation · 2023
- Descendant · 2 generations on · 1 of its ownK240389 Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 )…Hyundae Meditech Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK252171 Barbed PDO SutureSutura Medical Technology, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK242571 Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150…Hyundae Meditech Co., Ltd. · 2024
Most influential descendants
Showing 4 of 4 · See all- K220549MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043…Hans Biomed Corporation · 2023 · cites it directly2descendants
- K240389Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread…Hyundae Meditech Co., Ltd. · 2024 · 2 generations on1descendant
- K252171Barbed PDO SutureSutura Medical Technology, Inc. · 2026 · cites it directly0descendants
- K242571Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150…Hyundae Meditech Co., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K142061 | Silhouette Instalift | Silhouette Lift, Inc. | 2015 | — |
| −1 | K163676 | Silhouette InstaLift | Silhouette Lift, Inc. | 2017 | — |
| 0 (this device) | K192423 | MINT Product Family | Hans Biomed Corporation | 2020 | — |
| +1 | K220549 | MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift… | Hans Biomed Corporation | 2023 | — |
| +2 | K240389 | Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread… | Hyundae Meditech Co., Ltd. | 2024 | — |
| +1 | K252171 | Barbed PDO Suture | Sutura Medical Technology, Inc. | 2026 | — |
| +3 | K242571 | Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150… | Hyundae Meditech Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 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 NEW? 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 NEW device
- #1 K252047 STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue…score 15.3 · 14 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 |
|---|---|---|---|
| * | K163676 | Silhouette InstaLiftSummary page 5…lassification Panel: General & Plastic Surgery 5. Legally Marketed Predicate Device(s) The primary predicate is the Silhouette InstaLift™ device cleared under K163676 by Silhouette Lift, Inc. The reference device is the original MINT™ device cleared under K130191 by Hans Biomed Corporation.… | 2017 |
| † | K130191 | MINT | 2013 |
What descends from it? (4)
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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K220549 (Hans Biomed Corporation, 2023) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K163676.
How does its category compare?
All NEW devicesNEW Suture, Surgical, Absorbable, Polydioxanone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · NEW
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEW
146in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEW
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NEW
2,504in 2025
MAUDE reports naming product code NEW, 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 | 2 | — | 0 | 7 |
| 2008 | 5 | 22 | 1 | 29 |
| 2009 | 0 | — | 4 | 42 |
| 2010 | 3 | 270 | 0 | 115 |
| 2011 | 1 | — | 0 | 59 |
| 2012 | 3 | 113 | 1 | 82 |
| 2013 | 5 | 32 | 1 | 185 |
| 2014 | 1 | — | 1 | 274 |
| 2015 | 2 | — | 0 | 280 |
| 2016 | 3 | 254 | 0 | 321 |
| 2017 | 1 | — | 0 | 461 |
| 2018 | 3 | 441 | 0 | 900 |
| 2019 | 4 | 144 | 2 | 1,122 |
| 2020 | 3 | 230 | 0 | 1,010 |
| 2021 | 1 | — | 0 | 1,466 |
| 2022 | 1 | — | 1 | 1,537 |
| 2023 | 1 | — | 0 | 1,975 |
| 2024 | 3 | 48 | 0 | 2,114 |
| 2025 | 6 | 146 | 0 | 2,504 |
| 2026 | 5 | 264 | 0 | — |
What is it indicated for?
MINT™ is indicated for use in mid-face suspension surgery to temporarily fixate the cheek subcutaneous fat layer and SMAS layer in an elevated position for the treatment of moderate to severe nasolabial folds.
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/K192423 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192423: MINT Product Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192423
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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