510(k) · Cleared
ClearedMINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014
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 Mar 7, 2023 as substantially equivalent to K192423 (Hans Biomed Corporation, 2020) after a 375-day review. Its family tree reaches back 3 generations to 2015. 2 later devices descend from it.
- Decided
- Mar 7, 2023
- Review
- 375 days
- Class
- Class II
- Product code
- NEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K142061 (2015). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK142061 Silhouette InstaliftSilhouette Lift, Inc. · 2015
- 2 generations backK163676 Silhouette InstaLiftSilhouette Lift, Inc. · 2017
- 1 generation backK192423 MINT Product FamilyHans Biomed Corporation · 2020
- This deviceK220549 MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures)…Hans Biomed Corporation · 2023
- Descendant · cites it directly · 1 of its ownK240389 Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 )…Hyundae Meditech Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK242571 Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150…Hyundae Meditech Co., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See all- K240389Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread…Hyundae Meditech Co., Ltd. · 2024 · cites it directly1descendant
- K242571Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150…Hyundae Meditech Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K142061 | Silhouette Instalift | Silhouette Lift, Inc. | 2015 | — |
| −2 | K163676 | Silhouette InstaLift | Silhouette Lift, Inc. | 2017 | — |
| −1 | K192423 | MINT Product Family | Hans Biomed Corporation | 2020 | — |
| 0 (this device) | K220549 | MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift… | Hans Biomed Corporation | 2023 | — |
| +1 | K240389 | Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread… | Hyundae Meditech Co., Ltd. | 2024 | — |
| +2 | 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 |
|---|---|---|
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K192423 | MINT Product FamilySummary page 5…valence Claimed to Predicate Device The MINT Product Family (including MINT, MINT Lift, and MINT-I Sutures) is equivalent to the MINT Product Family (cleared in K192423), manufactured by Hans Biomed Corporation. Miracu (K172602), PDS Barbed Suture, PDO MAXX Threads (K190245), Demetech PDO Abso… | 2020 |
| † | K172602 | Miracu | 2018 |
| † | K190245 | PDS Barbed Suture, PDO MAXX Threads | 2019 |
| † | K082097 | Demetech Polydioxanone Synthetic Monofilament (Pdo) Absorbable Suture | 2010 |
| † | K130191 | MINT | 2013 |
| † | K163676 | Silhouette InstaLift | 2017 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240389 | Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread… | 2024 | 1 |
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 8 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K240389 (Hyundae Meditech Co., Ltd., 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K192423.
How does its category compare?
All NEW devicesNEW Suture, Surgical, Absorbable, Polydioxanone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Product Family (Including MINT, MINT Lift, and MINT-I Sutures) are comprised of PDO and are indicated for use in soft tissue approximation where use of a barbed absorbable suture is appropriate.
These sutures are also indicated for use in face suspension surgery to temporarily fixate the cheek sub dermis in an elevated position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220549: MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220549
Report an extraction error
Are you the manufacturer?
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