Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nanowear, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232053 | SimpleSense-BP, SimpleSense-BP Software Application | Nanowear, Inc. | 2023-12-08 | 150 | 0 |
| K212160 | SimpleSENSE Platform | Nanowear, Inc. | 2021-09-22 | 72 | 0 |
| K201669 | SimpleSENSE | Nanowear, Inc. | 2020-11-06 | 140 | 0 |
| K161431 | SimplECG | Nanowear, Inc. | 2016-11-30 | 190 | 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