Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nanoentek USA, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
260 daysmedian FDA review time
304 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162378 | FREND PSA PLUS (reagent cartridge) | Nanoentek USA, Inc. | 2017-05-17 | 266 | 0 |
| K162754 | FREND Vitamin D Test System | Nanoentek USA, Inc. | 2017-01-12 | 104 | 0 |
| K153577 | FREND Testosterone Test System | Nanoentek USA, Inc. | 2016-10-14 | 304 | 0 |
| K152422 | FREND™ Free T4 Test System | Nanoentek USA, Inc. | 2016-02-17 | 175 | 0 |
| K131928 | FREND TSH (REAGENT CARTRIDGE) | Nanoentek USA, Inc. | 2014-03-14 | 260 | 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