Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Micro Direct, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
182 daysmedian FDA review time
638 days90th percentile
9clearances measured
| 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 |
| K031102 | MICROLAB SPIROMETER | Micro Direct, Inc. | 2003-12-01 | 238 | 0 |
| K030586 | MICROPEAK | Micro Direct, Inc. | 2003-08-27 | 184 | 0 |
| K973314 | SPIROSAFE FILTER | Micro Direct, Inc. | 1997-11-21 | 79 | 0 |
| K965042 | MICRODL DIARYCARD SPIROMETER | Micro Direct, Inc. | 1997-06-17 | 182 | 0 |
| K963376 | MICRO H2 | Micro Direct, Inc. | 1997-01-24 | 150 | 0 |
| K963035 | MICRO SPIROMETER | Micro Direct, Inc. | 1996-11-01 | 88 | 0 |
| K950197 | MICROCO | Micro Direct, Inc. | 1996-10-17 | 638 | 0 |
| K940375 | MICRO MPM | Micro Direct, Inc. | 1994-11-21 | 299 | 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