Oriental System Technology, Inc.: FDA clearances and approvals
Oriental System Technology, Inc. has 6 FDA 510(k) clearances (first 1999, latest 2004), across 1 product code in 1 review panel. Median 510(k) review time: 56 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 | 6 | 6 |
Review panels
- General Hospital (6)
Most recent Oriental System Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K042202 | TEMPTELLER - HIGH SPEED DIGITAL THERMOMETERS, MODELS DT-302, DT-312, DT-412, DT-502 | FLL | 2004-09-10 | 28 |
| K030299 | TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX | FLL | 2003-02-25 | 27 |
| K010235 | TEMPTELLER INFRARED EAR THERMOMETER, MODEL CT-30/ CT-30DX | FLL | 2001-07-09 | 165 |
| K001008 | TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921 | FLL | 2000-04-12 | 14 |
| K992601 | TEMP TELLER - DIGITAL THERMOMETER, MODELS DT-101, DT-102, DT-103, DT-201, DT-202, DT-203 | FLL | 1999-10-27 | 85 |
| K984497 | TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201 | FLL | 1999-05-26 | 160 |
Recalls
openFDA lists no recalls under a recalling firm named Oriental System Technology, Inc..
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 Oriental System Technology, Inc. have?
Oriental System Technology, Inc. has 6 FDA 510(k) clearances (first 1999, latest 2004), across 1 product code in 1 review panel.
How long does FDA take to clear Oriental System Technology, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Oriental System Technology, Inc.'s cleared 510(k)s is 56 days.
What devices does Oriental System Technology, Inc. make?
Its most frequent FDA product codes are FLL (Continuous Measurement Thermometer, 6).
Has Oriental System Technology, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Oriental System Technology, Inc. Related entities may recall under other names.
Next steps
- See all 6 Oriental System Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FLL, Oriental System Technology, Inc.'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.