# K254238: MINT MONO Sutures

- Pathway: 510(k) (Traditional)
- Applicant: Hans Biomed Corporation
- Decided: Sep 18, 2026 after 263 days
- Product code: NEW (Suture, Surgical, Absorbable, Polydioxanone)
- Device class: 2
- Regulation: 21 CFR 878.4840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K013274 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181582: DemeTECH DemeDIOX absorbable surgical suture, Demetech Corporation (2018) Summary page 5.

## Indications for use
MINT MONO Sutures are comprised of PDO and are indicated for use in soft tissue approximation where use of an absorbable suture is appropriate. The suture is not intended for lifting or filling aesthetic uses.

Source page: https://510kreport.com/device/K254238
Methodology: https://510kreport.com/methodology