Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nano4imaging GmbH — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253262 | EmeryGlide™ (EG18008901) | Nano4imaging GmbH | 2026-03-06 | 158 | 0 |
| K173423 | MR Wire Guide Wire Straight, MR Wire Guide Wire Angled | Nano4imaging GmbH | 2017-11-17 | 16 | 0 |
| K160594 | MRWire Guide Wire | Nano4imaging GmbH | 2016-11-22 | 266 | 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