Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ndd Medizintechnik AG — 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) |
|---|---|---|---|---|---|
| K230178 | EasyOne Sky Spirometer | Ndd Medizintechnik AG | 2023-10-19 | 269 | 0 |
| K221250 | EasyOne Filter | Ndd Medizintechnik AG | 2022-11-22 | 204 | 0 |
| K161534 | EasyOne Pro Respiratory Analysis System | Ndd Medizintechnik AG | 2017-02-22 | 264 | 0 |
| K161536 | EasyOne Air Spirometer | Ndd Medizintechnik AG | 2017-01-05 | 216 | 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