Sm Eng Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Sm Eng Co., Ltd.” (first 2017, latest 2020), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 242 days. Since 2017 the median was 242 days, against 134 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 2 | 252 |
| 2018 | 2 | 234 |
| 2019 | 0 | — |
| 2020 | 1 | 140 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sm Eng Co., Ltd. took a median 242 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 134 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 3 | 3 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | 1 | 1 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 1 | 1 |
Review panels
Most recent Sm Eng Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200392 | REXSIN | GAM | 2020-07-07 | 140 |
| K173747 | REXLENE | GAW | 2018-12-21 | 378 |
| K173779 | REXMONO, PDREX | GAM | 2018-03-12 | 90 |
| K161633 | REXLON, REXSIL | GAR | 2017-03-02 | 262 |
| K161629 | CRYLREX | GAM | 2017-02-10 | 242 |
Recalls
openFDA lists no recalls under a recalling firm named Sm Eng Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Sm Eng Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Sm Eng Co., Ltd.” (first 2017, latest 2020), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sm Eng Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sm Eng Co., Ltd. is 242 days. Since 2017: 242 days, versus 134 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Sm Eng Co., Ltd.?
The most frequent FDA product codes under this applicant name are GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid, 3); GAR (Suture, Nonabsorbable, Synthetic, Polyamide, 1); GAW (Suture, Nonabsorbable, Synthetic, Polypropylene, 1).
Next steps
- See all 5 Sm Eng Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GAM, Sm Eng Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.