Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Foshan Gaunying Electronics Co., Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
126 daysmedian FDA review time
203 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140211 | ULTRASONIC MESH NEBULIZER | Foshan Gaunying Electronics Co., Ltd. | 2014-05-30 | 122 | 0 |
| K132247 | ULTRASONIC MESH NEBULIZER | Foshan Gaunying Electronics Co., Ltd. | 2014-01-08 | 173 | 0 |
| K121154 | ULTRASONIC NEBULIZER | Foshan Gaunying Electronics Co., Ltd. | 2012-08-20 | 126 | 0 |
| K110721 | GAUNYING INFRARED LAMP | Foshan Gaunying Electronics Co., Ltd. | 2011-03-30 | 15 | 0 |
| K101693 | GAUNYING INFRARED LAMP MODEL IL50 | Foshan Gaunying Electronics Co., Ltd. | 2011-01-05 | 203 | 0 |
| K102149 | GAUNYING INFRARED LAMP | Foshan Gaunying Electronics Co., Ltd. | 2010-08-13 | 14 | 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