Guangdong Biolight Meditech Co., Ltd.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Guangdong Biolight Meditech Co., Ltd.” (first 2008, latest 2019), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 139 days. Since 2017 the median was 148 days, against 195 days for all cleared 510(k)s in the same product codes. 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 | 3 | 126 |
| 2013 | 1 | 28 |
| 2014 | 4 | 337 |
| 2015 | 0 | — |
| 2016 | 5 | 237 |
| 2017 | 2 | 120 |
| 2018 | 0 | — |
| 2019 | 1 | 261 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Guangdong Biolight Meditech Co., Ltd. took a median 148 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 195 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 7 | 7 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 5 | 5 |
| DQA | Oximeter | 4 | 4 |
| HGM | System, Monitoring, Perinatal | 2 | 2 |
| DPS | Electrocardiograph | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
Review panels
Most recent Guangdong Biolight Meditech Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K181919 | Patient Monitor | MWI | 2019-04-05 | 261 |
| K170514 | Central Monitoring System | MHX | 2017-05-24 | 92 |
| K162234 | Truscope Ultra Patient Monitor | MWI | 2017-01-04 | 148 |
| K160349 | Electronic Sphygmomanometer | DXN | 2016-11-03 | 269 |
| K153580 | Central Monitoring System | HGM | 2016-09-07 | 267 |
| K153135 | VITAL SIGNS MONITOR | MWI | 2016-02-25 | 118 |
| K152739 | Electronic Thermometer | FLL | 2016-02-09 | 139 |
| K151287 | Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D | DQA | 2016-01-06 | 237 |
| K131858 | DIGITAL ELECTROCARDIOGRAPH | DPS | 2014-06-11 | 352 |
| K131762 | HANDHELD MONITOR | MWI | 2014-06-06 | 354 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Guangdong Biolight Meditech 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.
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.
- Guangdong Transtek Medical Electronics Co., Ltd. (17 510(k)s)
- Guangdong Kingfa Sci. & Tech.Co., Ltd. (14 510(k)s)
- Guangdong Optomedic Technologies, Inc. (9 510(k)s)
- Guangdong Horigen Mother & Baby Products Co., Ltd. (7 510(k)s)
- Guangdong Genial Technology Co., Ltd. (5 510(k)s)
- Guangdong Newdermo Biotech Co., Ltd. (5 510(k)s)
- Guangdong Prestige Technology Co., Ltd. (5 510(k)s)
- Guangdong Jinme Medical Technology Co., Ltd. (4 510(k)s)
- Guangdong Youmeng Electrical Technology Co., Ltd. (4 510(k)s)
- Guangdong Gymda Medical Technology Co.,Ltd (2 510(k)s)
- Guangdong Kaiyang Medical Technology Co., Ltd. (2 510(k)s)
- Guangdong Xinyu Electronic and Technology Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Guangdong Biolight Meditech Co., Ltd.?
FDA lists 21 510(k) clearances under the applicant name “Guangdong Biolight Meditech Co., Ltd.” (first 2008, latest 2019), across 7 product codes in 4 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 Guangdong Biolight Meditech Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Guangdong Biolight Meditech Co., Ltd. is 139 days. Since 2017: 148 days, versus 195 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Guangdong Biolight Meditech Co., Ltd.?
The most frequent FDA product codes under this applicant name are MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), 7); MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 5); DQA (Oximeter, 4).
Next steps
- See all 21 Guangdong Biolight Meditech Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MWI, Guangdong Biolight Meditech 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.