Medcraft Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Medcraft Corp.” (first 1976, latest 1986), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 6 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| DPS | Electrocardiograph | 2 | 2 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
| IOL | Treadmill, Powered | 1 | 1 |
| QGH | Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder | 1 | 1 |
Review panels
- Cardiovascular (3)
- Neurology (1)
- Physical Medicine (1)
Most recent Medcraft Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K860467 | ELECTROSHOCK UNIT NEUROLOGY MODEL B-25 | QGH | 1986-11-10 | 277 |
| K791795 | COMP-ACT IV | DPS | 1979-09-27 | 13 |
| K760510 | MONITORING SYSTEM, REHABILITATION | DPS | 1976-08-30 | 6 |
| K760509 | TREADMILL, DIAGNOSTIC | IOL | 1976-08-30 | 6 |
| K760508 | ACCUTAPE 24 | DSH | 1976-08-30 | 6 |
Recalls
openFDA lists no recalls under a recalling firm named Medcraft Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Medcraft Corp.?
FDA lists 5 510(k) clearances under the applicant name “Medcraft Corp.” (first 1976, latest 1986), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medcraft Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medcraft Corp. is 6 days.
Which FDA product codes appear under Medcraft Corp.?
The most frequent FDA product codes under this applicant name are DPS (Electrocardiograph, 2); DSH (Recorder, Magnetic Tape, Medical, 1); IOL (Treadmill, Powered, 1).
Next steps
- See all 5 Medcraft Corp. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Medcraft Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.