Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sime Health, Ltd. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
280 daysmedian FDA review time
437 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K954025 | SIME SURGICAL POWDERFREE | Sime Health, Ltd. | 1995-11-15 | 79 | 0 |
| K954051 | SIME POWDERFREE PLUS | Sime Health, Ltd. | 1995-11-15 | 78 | 0 |
| K932985 | AROMATIC CONDOM, ESSENTIALS, MI VIDA & JIFFI | Sime Health, Ltd. | 1995-06-16 | 728 | 0 |
| K932983 | COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI) | Sime Health, Ltd. | 1994-07-07 | 384 | 0 |
| K932984 | UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFI | Sime Health, Ltd. | 1994-07-07 | 384 | 0 |
| K932982 | SPERMICIDAL LUBRIC. CONDOMS (ESSENTIALS, MI VIDA, JIFFI) | Sime Health, Ltd. | 1994-07-07 | 384 | 0 |
| K940797 | SIME SURGICAL LATEX GLOVE | Sime Health, Ltd. | 1994-05-09 | 76 | 0 |
| K931491 | SIME HEALTH SIME HYPOALLERGENIC | Sime Health, Ltd. | 1993-10-15 | 204 | 0 |
| K914276 | SIME HEALTH SIME POWDERFREE EXAMINATION GLOVES | Sime Health, Ltd. | 1992-12-04 | 437 | 0 |
| K913813 | JIFFI CONDOM (RUBBER) CONTRACEPTIVE | Sime Health, Ltd. | 1992-06-01 | 280 | 0 |
| K913048 | SIME TRUFEEL | Sime Health, Ltd. | 1991-09-19 | 72 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda