Sime Health, Ltd.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Sime Health, Ltd.” (first 1991, latest 1995), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 280 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HIS | Condom | 5 | 5 |
| LYY | Latex Patient Examination Glove | 4 | 4 |
| KGO | Surgeon'S Gloves | 2 | 2 |
Review panels
Most recent Sime Health, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954051 | SIME POWDERFREE PLUS | LYY | 1995-11-15 | 78 |
| K954025 | SIME SURGICAL POWDERFREE | KGO | 1995-11-15 | 79 |
| K932985 | AROMATIC CONDOM, ESSENTIALS, MI VIDA & JIFFI | HIS | 1995-06-16 | 728 |
| K932984 | UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFI | HIS | 1994-07-07 | 384 |
| K932983 | COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI) | HIS | 1994-07-07 | 384 |
| K932982 | SPERMICIDAL LUBRIC. CONDOMS (ESSENTIALS, MI VIDA, JIFFI) | HIS | 1994-07-07 | 384 |
| K940797 | SIME SURGICAL LATEX GLOVE | KGO | 1994-05-09 | 76 |
| K931491 | SIME HEALTH SIME HYPOALLERGENIC | LYY | 1993-10-15 | 204 |
| K914276 | SIME HEALTH SIME POWDERFREE EXAMINATION GLOVES | LYY | 1992-12-04 | 437 |
| K913813 | JIFFI CONDOM (RUBBER) CONTRACEPTIVE | HIS | 1992-06-01 | 280 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sime Health, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Sime Darby USA (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sime Health, Ltd.?
FDA lists 11 510(k) clearances under the applicant name “Sime Health, Ltd.” (first 1991, latest 1995), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sime Health, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sime Health, Ltd. is 280 days.
Which FDA product codes appear under Sime Health, Ltd.?
The most frequent FDA product codes under this applicant name are HIS (Condom, 5); LYY (Latex Patient Examination Glove, 4); KGO (Surgeon'S Gloves, 2).
Next steps
- See all 11 Sime Health, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HIS, Sime Health, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.