Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Assure Tech. (Hangzhou) Co, Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
117 daysmedian FDA review time
422 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233174 | FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid | Assure Tech. (Hangzhou) Co, Ltd. | 2024-02-05 | 130 | 0 |
| K201630 | AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA I | Assure Tech. (Hangzhou) Co, Ltd. | 2021-08-12 | 422 | 0 |
| K181768 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | Assure Tech. (Hangzhou) Co, Ltd. | 2018-08-20 | 48 | 0 |
| K180349 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | Assure Tech. (Hangzhou) Co, Ltd. | 2018-04-05 | 56 | 0 |
| K170049 | AssureTech Panel Dip Test, AssureTech Quick Cup Test | Assure Tech. (Hangzhou) Co, Ltd. | 2017-05-02 | 117 | 0 |
| K161044 | AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cu | Assure Tech. (Hangzhou) Co, Ltd. | 2016-07-06 | 84 | 0 |
| K153465 | AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Tu | Assure Tech. (Hangzhou) Co, Ltd. | 2016-03-31 | 121 | 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