Mesure Technology Co., Ltd.: FDA clearances and approvals
Mesure Technology Co., Ltd. has 13 FDA 510(k) clearances (first 1996, latest 2008), across 1 product code in 1 review panel. Median 510(k) review time: 43 days.
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 |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | 13 | 13 |
Review panels
- General Hospital (13)
Most recent Mesure Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K080981 | EAR THERMOMETER, MODELS ST66 AND ST67 | FLL | 2008-05-02 | 25 |
| K071019 | DIGITAL CLINICAL THERMOMETER/MODELS ST8C SERIES | FLL | 2007-04-27 | 17 |
| K063542 | WIRELESS TEMPERATURE MONITOR / MODELS ST323C AND ST323F. | FLL | 2007-04-10 | 137 |
| K050303 | 5 SEC DIGITAL CLINICAL THERMOMETER, MODELS ST8630X, ST8640X, ST8730X, ST8740X, ST8930X, ST8940X, ST8030X, ST8040X. | FLL | 2005-02-25 | 17 |
| K042627 | EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65 | FLL | 2004-10-18 | 21 |
| K042013 | DIGITAL CLINICAL THERMOMETER, MODELS ST-8A3C AND ST-8A3F | FLL | 2004-09-08 | 43 |
| K023956 | THERMOMETER MODELS ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F | FLL | 2004-06-17 | 568 |
| K041056 | 10-SECOND DIGITAL THERMOMETER, MODELS ST87, ST89, ST80, ST88 | FLL | 2004-05-12 | 19 |
| K013779 | THERMOMETER MODELS ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, AND ST8542F | FLL | 2002-03-29 | 136 |
| K011254 | EAR THERMOMETER, MODELS ST613C AND ST613F | FLL | 2001-07-10 | 77 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mesure Technology Co., 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.
Frequently asked questions
How many FDA 510(k) clearances does Mesure Technology Co., Ltd. have?
Mesure Technology Co., Ltd. has 13 FDA 510(k) clearances (first 1996, latest 2008), across 1 product code in 1 review panel.
How long does FDA take to clear Mesure Technology Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Mesure Technology Co., Ltd.'s cleared 510(k)s is 43 days.
What devices does Mesure Technology Co., Ltd. make?
Its most frequent FDA product codes are FLL (Continuous Measurement Thermometer, 13).
Has Mesure Technology Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Mesure Technology Co., Ltd. Related entities may recall under other names.
Next steps
- See all 13 Mesure Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FLL, Mesure Technology Co., 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.