Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medisim, Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
126 daysmedian FDA review time
465 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150160 | Temple Touch Pro (TTP) Non-invasive temperature monitoring s | Medisim, Ltd. | 2015-10-20 | 270 | 0 |
| K131155 | UGFT3; FHT7 | Medisim, Ltd. | 2013-08-28 | 126 | 0 |
| K090386 | NON-INVASIVE INFRARED (NIR) | Medisim, Ltd. | 2010-05-28 | 465 | 0 |
| K051422 | DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE | Medisim, Ltd. | 2005-09-01 | 92 | 0 |
| K032362 | UP-GRADE FOREHEAD THERMOMETER | Medisim, Ltd. | 2003-12-04 | 126 | 0 |
| K012217 | M5T INSTANT FEVER THERMOMETER | Medisim, Ltd. | 2001-08-01 | 16 | 0 |
| K983887 | UP-GRADE AND UP-GRADE PRO | Medisim, Ltd. | 1999-02-12 | 102 | 1 |
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