Medi-Craft , Ltd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Medi-Craft , Ltd.” (first 1980, latest 1986), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 35 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 3 | 3 |
| BSY | Catheters, Suction, Tracheobronchial | 2 | 2 |
| BYX | Tubing, Pressure And Accessories | 2 | 2 |
| BZB | Catheter, Nasal, Oxygen | 1 | 1 |
| KOD | Catheter, Urological | 1 | 1 |
Review panels
Most recent Medi-Craft , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K861949 | SUCTION CATHETER KIT | BSY | 1986-10-22 | 155 |
| K800510 | RECTAL & HARRIS FLUSH TUBES | KNT | 1980-04-08 | 35 |
| K800508 | STOMACH TUBES | KNT | 1980-04-08 | 35 |
| K800507 | FEEDING TUBES | KNT | 1980-04-08 | 35 |
| K800505 | URETHRAL CATHETER | KOD | 1980-04-08 | 35 |
| K800509 | CONNECTING TUBES | BYX | 1980-03-25 | 21 |
| K800506 | OXYGEN CATHETER | BZB | 1980-03-25 | 21 |
| K800504 | OXYGEN CONNECTING TUBES | BYX | 1980-03-18 | 14 |
| K800503 | SUCTION CATHETER | BSY | 1980-03-18 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Medi-Craft , Ltd..
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 Medi-Craft , Ltd.?
FDA lists 9 510(k) clearances under the applicant name “Medi-Craft , Ltd.” (first 1980, latest 1986), across 5 product codes in 2 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 Medi-Craft , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medi-Craft , Ltd. is 35 days.
Which FDA product codes appear under Medi-Craft , Ltd.?
The most frequent FDA product codes under this applicant name are KNT (Tubes, Gastrointestinal (And Accessories), 3); BSY (Catheters, Suction, Tracheobronchial, 2); BYX (Tubing, Pressure And Accessories, 2).
Next steps
- See all 9 Medi-Craft , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KNT, Medi-Craft , Ltd.'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.