Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NRH — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K033688 | MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILIT | Micro Direct, Inc. | 2004-05-19 | 177 | 0 |
| K963376 | MICRO H2 | Micro Direct, Inc. | 1997-01-24 | 150 | 0 |
| K882499 | JAYCO HYDROGEN MONITOR | Enteron, Inc. | 1988-06-28 | 11 | 0 |
| K874892 | VITALOGRAPH-EC60 HYDROGEN MONITOR | Vitalograph , Ltd. | 1988-06-02 | 184 | 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