Machida America, Inc.: FDA clearances and approvals
Machida America, Inc. has 8 FDA 510(k) clearances (first 1981, latest 1988), across 4 product codes in 3 review panels. Median 510(k) review time: 42 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EQN | Laryngoscope, Nasopharyngoscope | 4 | 4 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 2 | 2 |
| HRX | Arthroscope | 1 | 1 |
| NVE | Washer, Cleaner, Automated, Endoscope | 1 | 1 |
Review panels
- Ear, Nose and Throat (6)
- General Hospital (1)
- Orthopedic (1)
Most recent Machida America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K871712 | MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT. | NVE | 1988-01-14 | 255 |
| K854581 | MACHIDA SEMI-RIGID BRONCHOSCOPE FBS-6R-50 | EOQ | 1986-02-28 | 105 |
| K844834 | MACHIDA FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE FNS-1 | EOQ | 1985-06-11 | 181 |
| K841087 | FLEXIBLE ORTHOPEDIC ENDOSCOPE ICA-1000 | HRX | 1984-05-16 | 64 |
| K821182 | MODEL ENT-4L-FLEXIBLE NASOPHARYNGO- | EQN | 1982-05-13 | 16 |
| K821181 | FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE # | EQN | 1982-05-13 | 16 |
| K812734 | MACHIDA FLEXIBLE INTUBATION SCOPE FLS-P | EQN | 1981-10-19 | 20 |
| K811943 | MACHIDA NASOPHARYNGO-LARYNGOSCOPE | EQN | 1981-07-28 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Machida America, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Machida America, Inc. have?
Machida America, Inc. has 8 FDA 510(k) clearances (first 1981, latest 1988), across 4 product codes in 3 review panels.
How long does FDA take to clear Machida America, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Machida America, Inc.'s cleared 510(k)s is 42 days.
What devices does Machida America, Inc. make?
Its most frequent FDA product codes are EQN (Laryngoscope, Nasopharyngoscope, 4); EOQ (Bronchoscope (Flexible Or Rigid), 2); HRX (Arthroscope, 1).
Has Machida America, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Machida America, Inc. Related entities may recall under other names.
Next steps
- See all 8 Machida America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EQN, Machida America, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.