Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
New Deantronics Taiwan , Ltd. — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
52 daysmedian FDA review time
176 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251492 | Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan , Ltd. | 2026-06-29 | 410 | 0 |
| K251899 | E Blator | New Deantronics Taiwan , Ltd. | 2025-10-01 | 103 | 0 |
| K202962 | Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, S | New Deantronics Taiwan , Ltd. | 2020-11-20 | 51 | 0 |
| K201221 | Electrosurgical Generator | New Deantronics Taiwan , Ltd. | 2020-09-28 | 145 | 0 |
| K200455 | Trigger Switch and Cord | New Deantronics Taiwan , Ltd. | 2020-03-31 | 35 | 0 |
| K193004 | Monopolar Cord | New Deantronics Taiwan , Ltd. | 2019-12-19 | 52 | 0 |
| K191064 | Argon Handset | New Deantronics Taiwan , Ltd. | 2019-06-12 | 51 | 0 |
| K183126 | Electrosurgical accessory | New Deantronics Taiwan , Ltd. | 2019-05-08 | 176 | 0 |
| K183594 | Laparoscopic Curved Spatula Electrode, Retractable, Aspirati | New Deantronics Taiwan , Ltd. | 2019-02-19 | 60 | 0 |
| K180908 | Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan , Ltd. | 2018-05-18 | 42 | 0 |
| K170161 | New Deantronics E Green™ Electrosurgical Monopolar Pencils | New Deantronics Taiwan , Ltd. | 2017-03-29 | 70 | 0 |
| K153265 | New Deantronics Disposable Laparoscopic Electrodes, non-coat | New Deantronics Taiwan , Ltd. | 2016-01-05 | 54 | 0 |
| K152031 | New Deantronics Smoke Evacuation Adapter with 10mm connector | New Deantronics Taiwan , Ltd. | 2015-09-17 | 57 | 0 |
| K982748 | BI-POLAR CORD SET 1.88 TR, BI-POLAR CORD SET 1.83 TR, MODEL | New Deantronics Taiwan , Ltd. | 1998-11-03 | 89 | 0 |
| K982749 | MONOPOLAR FOOT CONTROL PENCIL, MODEL # SB 112-2 | New Deantronics Taiwan , Ltd. | 1998-09-14 | 39 | 0 |
| K982743 | DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHO | New Deantronics Taiwan , Ltd. | 1998-09-14 | 39 | 0 |
| K982742 | DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH, ONE PIECE A | New Deantronics Taiwan , Ltd. | 1998-09-14 | 39 | 0 |
| K982746 | MONOPOLAR SUCTION COAGULATOR, MODEL # SB 110-1 | New Deantronics Taiwan , Ltd. | 1998-09-14 | 39 | 0 |
| K982744 | DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON, 2 PIECE WITH | New Deantronics Taiwan , Ltd. | 1998-09-11 | 36 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda