Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ndd Medizitechnik AG — 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) |
|---|---|---|---|---|---|
| K120635 | EASYONE PRO RESPIRATORY TESTING DEVICE | Ndd Medizitechnik AG | 2012-09-27 | 210 | 0 |
| K091428 | EASYONE PRO RESPIRATORY ANALYSIS SYSTEM | Ndd Medizitechnik AG | 2010-01-27 | 258 | 0 |
| K090034 | EASY ON-PC SPIROMETER | Ndd Medizitechnik AG | 2009-06-02 | 147 | 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