Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Co-Innovation Biotech Co., Ltd. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
139 daysmedian FDA review time
271 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241100 | Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl | Co-Innovation Biotech Co., Ltd. | 2024-05-22 | 30 | 0 |
| K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test D | Co-Innovation Biotech Co., Ltd. | 2024-03-08 | 254 | 0 |
| K232732 | Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) T | Co-Innovation Biotech Co., Ltd. | 2024-01-17 | 132 | 0 |
| K213808 | Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Te | Co-Innovation Biotech Co., Ltd. | 2022-04-05 | 120 | 0 |
| K153050 | Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Te | Co-Innovation Biotech Co., Ltd. | 2016-04-26 | 189 | 0 |
| K142800 | Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug | Co-Innovation Biotech Co., Ltd. | 2014-12-11 | 73 | 0 |
| K140748 | ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-D | Co-Innovation Biotech Co., Ltd. | 2014-08-20 | 148 | 0 |
| K140215 | ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD | Co-Innovation Biotech Co., Ltd. | 2014-06-16 | 139 | 0 |
| K131110 | ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/ | Co-Innovation Biotech Co., Ltd. | 2014-01-15 | 271 | 0 |
| K132085 | ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STE | Co-Innovation Biotech Co., Ltd. | 2013-11-12 | 130 | 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