New Deantronics Taiwan , Ltd.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “New Deantronics Taiwan , Ltd.” (first 1998, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 52 days. Since 2017 the median was 60 days, against 112 days for all cleared 510(k)s in the same product codes. 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 | 0 | — |
| 2015 | 1 | 57 |
| 2016 | 1 | 54 |
| 2017 | 1 | 70 |
| 2018 | 1 | 42 |
| 2019 | 4 | 56 |
| 2020 | 3 | 51 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 103 |
| 2026 | 1 | 410 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name New Deantronics Taiwan , Ltd. took a median 60 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 19 | 19 |
Review panels
Most recent New Deantronics Taiwan , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251492 | Irrigation Tubing Bipolar Cord Set | GEI | 2026-06-29 | 410 |
| K251899 | E Blator | GEI | 2025-10-01 | 103 |
| K202962 | Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D2, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D2, Telescopic Smoke Evacuation Button Switch Pencil, 10ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, Lock, 15ft | GEI | 2020-11-20 | 51 |
| K201221 | Electrosurgical Generator | GEI | 2020-09-28 | 145 |
| K200455 | Trigger Switch and Cord | GEI | 2020-03-31 | 35 |
| K193004 | Monopolar Cord | GEI | 2019-12-19 | 52 |
| K191064 | Argon Handset | GEI | 2019-06-12 | 51 |
| K183126 | Electrosurgical accessory | GEI | 2019-05-08 | 176 |
| K183594 | Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration, 36cm ; Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Straight Spatula Electrode, Hollow, 28cm ; Laparoscopic Curved Spatula Electrode, Hollow, 28cm; Laparoscopic Wire J | GEI | 2019-02-19 | 60 |
| K180908 | Irrigation Tubing Bipolar Cord Set | GEI | 2018-05-18 | 42 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named New Deantronics Taiwan , Ltd..
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 New Deantronics Taiwan , Ltd.?
FDA lists 19 510(k) clearances under the applicant name “New Deantronics Taiwan , Ltd.” (first 1998, latest 2026), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by New Deantronics Taiwan , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name New Deantronics Taiwan , Ltd. is 52 days. Since 2017: 60 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under New Deantronics Taiwan , Ltd.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 19).
Next steps
- See all 19 New Deantronics Taiwan , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEI, New Deantronics Taiwan , Ltd.'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.