# Sm Eng Co., Ltd.

- Location (FDA's records): Sasang-Gu, KR
- FDA decisions: 5 (2017–2020): 5 510(k) clearances
- Product codes: GAM (3), GAR (1), GAW (1)
- 510(k) review time since 2016: median 191 days, against 116 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 7 (0 its own); citations of its devices by later devices: 5 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Foosin Medical Supplies Inc., Ltd.: 6 (https://510kreport.com/company/foosin-medical-supplies)
- Myco Medical Supplies, Inc.: 1 (https://510kreport.com/company/myco-medical-supplies)

## Firms that cite its devices most
- Safepath Medical, Inc.: 3 (https://510kreport.com/company/safepath-medical)
- Shandong Haidike Medical Product Co., Ltd.: 1 (https://510kreport.com/company/shandong-haidike-medical-product)
- Antarma, LLC Dba Golnit Sutures: 1 (https://510kreport.com/company/antarma-dba-golnit-sutures)

## Its most-cited devices
- K161633: Rexlon, Rexsil (2017), cited by 4
- K173747: Rexlene (2018), cited by 1

## Recent decisions
- K200392: Rexsin (Jul 7, 2020)
- K173747: Rexlene (Dec 21, 2018)
- K173779: Rexmono, Pdrex (Mar 12, 2018)
- K161633: Rexlon, Rexsil (Mar 2, 2017)
- K161629: Crylrex (Feb 10, 2017)

Source page: https://510kreport.com/company/sm-eng