Medi-Plast Intl., Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Medi-Plast Intl., Inc.” (first 1981, latest 1996), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 44 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 |
|---|---|---|---|
| KPE | Container, I.V. | 4 | 4 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 2 | 2 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| FRG | Wrap, Sterilization | 1 | 1 |
| FSM | Tray, Surgical, Instrument | 1 | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Medi-Plast Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954284 | MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON) | DTL | 1996-02-12 | 166 |
| K873588 | 10CC CONTROL SYRINGE | FMF | 1987-10-23 | 49 |
| K863402 | MEDI-PLAST DISPOSABLE MANIFOLD | DTL | 1986-10-22 | 49 |
| K861785 | FLUOROSCOPE BAND BAG | JAA | 1986-06-13 | 36 |
| K851489 | ARTERIAL-VENOUS COMPRESSION DRESSING | — | 1985-06-11 | 57 |
| K842136 | STERILE PAN SET | FRG | 1984-07-06 | 37 |
| K840021 | OPERATING ROOM TRAY SET | FSM | 1984-03-15 | 70 |
| K840022 | HEART CATHETERIZATION TRAY SET | DRE | 1984-02-04 | 30 |
| K811268 | BOTTLE-TO-BOTTLE | KPE | 1981-06-18 | 44 |
| K811234 | I.V. BOTTLE (RIDGID) | KPE | 1981-06-18 | 45 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medi-Plast Intl., Inc..
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-Plast Intl., Inc.?
FDA lists 12 510(k) clearances under the applicant name “Medi-Plast Intl., Inc.” (first 1981, latest 1996), across 8 product codes in 4 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-Plast Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medi-Plast Intl., Inc. is 44 days.
Which FDA product codes appear under Medi-Plast Intl., Inc.?
The most frequent FDA product codes under this applicant name are KPE (Container, I.V., 4); DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, 2); DRE (Dilator, Vessel, For Percutaneous Catheterization, 1).
Next steps
- See all 12 Medi-Plast Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code KPE, Medi-Plast Intl., Inc.'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.