# MINT MONO Sutures (K254238): 510(k) cleared for Hans Biomed Corporation

**Predicate Speed & CAPA Advisory Opportunity Score:** 55/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K254238 |
| Device | MINT MONO Sutures |
| Applicant | Hans Biomed Corporation |
| Specialty / panel | General, Plastic Surgery |
| Product code | NEW |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-12-29 |
| Decision date | 2026-09-18 |
| Review time (days) | 263 |
| Third-party review | No |
| Applicant location | Yuseong-Gu, KR |

## Why this score
- A long 263-day review suggests additional-information requests: a firm likely to value regulatory help next time.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254238). Last refreshed: 2026-11-03T18:05:14.713Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.