Idt Technology Limited: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Idt Technology Limited” (first 2002, latest 2015), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 150 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 261 |
| 2015 | 1 | 147 |
| 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 4 | 4 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| MNW | Analyzer, Body Composition | 1 | 1 |
Review panels
Most recent Idt Technology Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151415 | Oregon Scientific | DXN | 2015-10-21 | 147 |
| K131245 | OREGON SCINTIFIC | DXN | 2014-01-17 | 261 |
| K050083 | BLOOD-PRESSURE METER, BPW120 | DXN | 2005-04-08 | 85 |
| K031167 | HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEX | MNW | 2004-01-28 | 289 |
| K020433 | FT101 FOREHEAD THERMOMETER; FT101 INFRARED DIGITAL THERMOMETER | FLL | 2002-07-11 | 153 |
| K021252 | BLOOD-PRESSURE METER | DXN | 2002-06-17 | 59 |
Recalls
openFDA lists no recalls under a recalling firm named Idt Technology Limited.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Idt Technology Limited?
FDA lists 6 510(k) clearances under the applicant name “Idt Technology Limited” (first 2002, latest 2015), across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Idt Technology Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Idt Technology Limited is 150 days.
Which FDA product codes appear under Idt Technology Limited?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 4); FLL (Continuous Measurement Thermometer, 1); MNW (Analyzer, Body Composition, 1).
Next steps
- See all 6 Idt Technology Limited clearances with predicates and recalls
- Run predicate analysis for product code DXN, Idt Technology Limited's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.