Medisim, Ltd.: FDA clearances and approvals
Medisim, Ltd. has 7 FDA 510(k) clearances (first 1999, latest 2015), across 1 product code in 1 review panel. Median 510(k) review time: 126 days. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 126 |
| 2014 | 0 | — |
| 2015 | 1 | 270 |
| 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 |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | 7 | 7 |
Review panels
- General Hospital (7)
Most recent Medisim, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K150160 | Temple Touch Pro (TTP) Non-invasive temperature monitoring system | FLL | 2015-10-20 | 270 |
| K131155 | UGFT3; FHT7 | FLL | 2013-08-28 | 126 |
| K090386 | NON-INVASIVE INFRARED (NIR) | FLL | 2010-05-28 | 465 |
| K051422 | DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE | FLL | 2005-09-01 | 92 |
| K032362 | UP-GRADE FOREHEAD THERMOMETER | FLL | 2003-12-04 | 126 |
| K012217 | M5T INSTANT FEVER THERMOMETER | FLL | 2001-08-01 | 16 |
| K983887 | UP-GRADE AND UP-GRADE PRO | FLL | 1999-02-12 | 102 |
Recalls
openFDA lists no recalls under a recalling firm named Medisim, Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Medisim, Ltd. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00760422: Clinical Evaluation of NIR (Non-Invasive Infrared) Thermometer Performance (Completed, started 2008-12)
Frequently asked questions
How many FDA 510(k) clearances does Medisim, Ltd. have?
Medisim, Ltd. has 7 FDA 510(k) clearances (first 1999, latest 2015), across 1 product code in 1 review panel.
How long does FDA take to clear Medisim, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Medisim, Ltd.'s cleared 510(k)s is 126 days.
What devices does Medisim, Ltd. make?
Its most frequent FDA product codes are FLL (Continuous Measurement Thermometer, 7).
Has Medisim, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Medisim, Ltd. Related entities may recall under other names.
Next steps
- See all 7 Medisim, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FLL, Medisim, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.