Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hangzhou Clongene Biotech Co., Ltd. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
51 daysmedian FDA review time
122 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253318 | Clungene RSV Antigen Rapid Test | Hangzhou Clongene Biotech Co., Ltd. | 2026-01-30 | 122 | 0 |
| K252118 | CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home | Hangzhou Clongene Biotech Co., Ltd. | 2025-08-27 | 51 | 0 |
| K242802 | CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test | Hangzhou Clongene Biotech Co., Ltd. | 2024-11-08 | 52 | 0 |
| K193132 | CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pre | Hangzhou Clongene Biotech Co., Ltd. | 2019-12-11 | 29 | 0 |
| K190412 | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test | Hangzhou Clongene Biotech Co., Ltd. | 2019-03-21 | 28 | 0 |
| K181790 | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test | Hangzhou Clongene Biotech Co., Ltd. | 2018-07-26 | 21 | 0 |
| K180255 | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test | Hangzhou Clongene Biotech Co., Ltd. | 2018-02-28 | 29 | 0 |
| K161251 | CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE | Hangzhou Clongene Biotech Co., Ltd. | 2016-08-30 | 119 | 0 |
| K153741 | CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNG | Hangzhou Clongene Biotech Co., Ltd. | 2016-03-18 | 81 | 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