Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Guangdong Biolight Meditech Co., Ltd. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
139 daysmedian FDA review time
322 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181919 | Patient Monitor | Guangdong Biolight Meditech Co., Ltd. | 2019-04-05 | 261 | 0 |
| K170514 | Central Monitoring System | Guangdong Biolight Meditech Co., Ltd. | 2017-05-24 | 92 | 0 |
| K162234 | Truscope Ultra Patient Monitor | Guangdong Biolight Meditech Co., Ltd. | 2017-01-04 | 148 | 0 |
| K160349 | Electronic Sphygmomanometer | Guangdong Biolight Meditech Co., Ltd. | 2016-11-03 | 269 | 0 |
| K153580 | Central Monitoring System | Guangdong Biolight Meditech Co., Ltd. | 2016-09-07 | 267 | 0 |
| K153135 | VITAL SIGNS MONITOR | Guangdong Biolight Meditech Co., Ltd. | 2016-02-25 | 118 | 0 |
| K152739 | Electronic Thermometer | Guangdong Biolight Meditech Co., Ltd. | 2016-02-09 | 139 | 0 |
| K151287 | Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D | Guangdong Biolight Meditech Co., Ltd. | 2016-01-06 | 237 | 0 |
| K131858 | DIGITAL ELECTROCARDIOGRAPH | Guangdong Biolight Meditech Co., Ltd. | 2014-06-11 | 352 | 0 |
| K131762 | HANDHELD MONITOR | Guangdong Biolight Meditech Co., Ltd. | 2014-06-06 | 354 | 0 |
| K131941 | FETAL MONITORS | Guangdong Biolight Meditech Co., Ltd. | 2014-05-15 | 322 | 0 |
| K131898 | A SERIES AND Q SERIES PATIENT MONITORS | Guangdong Biolight Meditech Co., Ltd. | 2014-02-18 | 238 | 0 |
| K131763 | TRUSCOPE SERIES PATIENT MONITOR | Guangdong Biolight Meditech Co., Ltd. | 2013-07-15 | 28 | 0 |
| K120193 | ANY VIEW PATIENT MONITORS | Guangdong Biolight Meditech Co., Ltd. | 2012-06-29 | 158 | 0 |
| K113833 | VITAL SIGNS MONITOR | Guangdong Biolight Meditech Co., Ltd. | 2012-05-01 | 126 | 0 |
| K112804 | FINGERTIP PULSE OXIMETER | Guangdong Biolight Meditech Co., Ltd. | 2012-01-27 | 122 | 0 |
| K112803 | PATIENT MONITOR | Guangdong Biolight Meditech Co., Ltd. | 2011-10-24 | 27 | 0 |
| K102040 | PATIENT MONITOR | Guangdong Biolight Meditech Co., Ltd. | 2010-09-24 | 67 | 0 |
| K101694 | HANDHELD PULSE OXIMETER MODEL M800 | Guangdong Biolight Meditech Co., Ltd. | 2010-09-08 | 84 | 0 |
| K100046 | M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000 | Guangdong Biolight Meditech Co., Ltd. | 2010-04-08 | 90 | 0 |
| K081712 | FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIM | Guangdong Biolight Meditech Co., Ltd. | 2008-09-12 | 87 | 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