Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Scivita Medical Technology Co., Ltd. · Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
239 daysmedian FDA review time
265 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251338 | Cholangioscope Visualization System (Single-use Video Cholan | Scivita Medical Technology Co., Ltd. | 2026-01-20 | 265 | 0 |
| K243708 | Urology Videoscope System (Single-use Flexible Ureteroscope: | Scivita Medical Technology Co., Ltd. | 2025-03-27 | 115 | 0 |
| K250210 | Broncho Videoscope System (Single-use Broncho Videoscope (SB | Scivita Medical Technology Co., Ltd. | 2025-03-19 | 54 | 0 |
| K240289 | Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, | Scivita Medical Technology Co., Ltd. | 2024-10-23 | 265 | 0 |
| K240192 | Single-use Extraction Baskets | Scivita Medical Technology Co., Ltd. | 2024-10-15 | 265 | 0 |
| K231521 | Broncho Videoscope System | Scivita Medical Technology Co., Ltd. | 2023-11-14 | 172 | 0 |
| K222812 | Insufflator | Scivita Medical Technology Co., Ltd. | 2023-05-16 | 239 | 0 |
| K221252 | Scivita 4KINSIGHT ICG Imaging System | Scivita Medical Technology Co., Ltd. | 2023-01-13 | 256 | 0 |
| K210379 | Broncho Videoscope System | Scivita Medical Technology Co., Ltd. | 2021-07-28 | 169 | 0 |
| K203255 | 4K UHD Laparoscope | Scivita Medical Technology Co., Ltd. | 2021-02-24 | 112 | 0 |
| K200216 | 4K UHD Camera System | Scivita Medical Technology Co., Ltd. | 2020-08-21 | 206 | 0 |
| K183675 | 3D Visualization System | Scivita Medical Technology Co., Ltd. | 2019-09-25 | 271 | 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