Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Guangdong Optomedic Technologies, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
134 daysmedian FDA review time
265 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252318 | Insufflator (OPTO-IFL1000) | Guangdong Optomedic Technologies, Inc. | 2026-04-16 | 265 | 0 |
| K252697 | 3D Laparoscope | Guangdong Optomedic Technologies, Inc. | 2025-10-29 | 63 | 0 |
| K242513 | FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K | Guangdong Optomedic Technologies, Inc. | 2024-10-23 | 61 | 0 |
| K241530 | Stellar Imaging System | Guangdong Optomedic Technologies, Inc. | 2024-08-07 | 69 | 0 |
| K231342 | Insufflator (OPTO-IFL1000) | Guangdong Optomedic Technologies, Inc. | 2023-09-20 | 134 | 0 |
| K230407 | FloNavi Open Field Fluorescence Imaging System | Guangdong Optomedic Technologies, Inc. | 2023-07-17 | 152 | 0 |
| K231003 | Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20 | Guangdong Optomedic Technologies, Inc. | 2023-07-06 | 90 | 0 |
| K221861 | FloNavi Endoscopic Fluorescence Imaging System | Guangdong Optomedic Technologies, Inc. | 2023-02-18 | 236 | 0 |
| K221781 | Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Mod | Guangdong Optomedic Technologies, Inc. | 2023-02-02 | 226 | 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