Foshan Gaunying Electronics Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Foshan Gaunying Electronics Co., Ltd.” (first 2010, latest 2014), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 124 days. 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 | 1 | 126 |
| 2013 | 0 | — |
| 2014 | 2 | 148 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 3 | 3 |
| ILY | Lamp, Infrared, Therapeutic Heating | 3 | 3 |
Review panels
- Anesthesiology (3)
- Physical Medicine (3)
Most recent Foshan Gaunying Electronics Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140211 | ULTRASONIC MESH NEBULIZER | CAF | 2014-05-30 | 122 |
| K132247 | ULTRASONIC MESH NEBULIZER | CAF | 2014-01-08 | 173 |
| K121154 | ULTRASONIC NEBULIZER | CAF | 2012-08-20 | 126 |
| K110721 | GAUNYING INFRARED LAMP | ILY | 2011-03-30 | 15 |
| K101693 | GAUNYING INFRARED LAMP MODEL IL50 | ILY | 2011-01-05 | 203 |
| K102149 | GAUNYING INFRARED LAMP | ILY | 2010-08-13 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Foshan Gaunying Electronics Co., 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Foshan Gaunying Electronics Co., Ltd. (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Foshan Nanhai Plus Medical Co, Ltd. (8 510(k)s)
- Foshan Coxo Medical Instrument Co., Ltd. (7 510(k)s)
- Foshan Care Medical Technology Co., Ltd. (4 510(k)s)
- Foshan Cicada Dental Instrument Co, Ltd. (4 510(k)s)
- Foshan Dahao Medical Technology Co., Ltd. (4 510(k)s)
- Foshan Pingchuang Medical Technology Co., Ltd. (3 510(k)s)
- Foshan United Medical Technologies, Ltd. (3 510(k)s)
- Foshan Hongfeng Co., Ltd. (2 510(k)s)
- Foshan Jindi Electric Appliance Co., Ltd. (2 510(k)s)
- Foshan Kycare Medical Equipment Co., Ltd. (2 510(k)s)
- Foshan Nanhai Bai HE Medical Technology Co., Ltd. (2 510(k)s)
- Foshan Topmed Dental Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Foshan Gaunying Electronics Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Foshan Gaunying Electronics Co., Ltd.” (first 2010, latest 2014), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Foshan Gaunying Electronics Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Foshan Gaunying Electronics Co., Ltd. is 124 days.
Which FDA product codes appear under Foshan Gaunying Electronics Co., Ltd.?
The most frequent FDA product codes under this applicant name are CAF (Nebulizer (Direct Patient Interface), 3); ILY (Lamp, Infrared, Therapeutic Heating, 3).
Next steps
- See all 6 Foshan Gaunying Electronics Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code CAF, Foshan Gaunying Electronics Co., 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.