Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Machida America, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
64 daysmedian FDA review time
255 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K871712 | MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT. | Machida America, Inc. | 1988-01-14 | 255 | 0 |
| K854581 | MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50 | Machida America, Inc. | 1986-02-28 | 105 | 0 |
| K844834 | MACHIDA FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE FNS-1 | Machida America, Inc. | 1985-06-11 | 181 | 0 |
| K841087 | FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000 | Machida America, Inc. | 1984-05-16 | 64 | 0 |
| K821182 | MODEL ENT-4L-FLEXIBLE NASOPHARYNGO- | Machida America, Inc. | 1982-05-13 | 16 | 0 |
| K821181 | FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE # | Machida America, Inc. | 1982-05-13 | 16 | 0 |
| K812734 | MACHIDA FLEXIBLE INTUBATION SCOPE FLS-P | Machida America, Inc. | 1981-10-19 | 20 | 0 |
| K811943 | MACHIDA NASOPHARYNGO-LARYNGOSCOPE | Machida America, Inc. | 1981-07-28 | 21 | 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