Med-Plastics Intl., Inc.: FDA clearances and approvals
Med-Plastics Intl., Inc. has 17 FDA 510(k) clearances (first 1993, latest 1995), across 8 product codes in 2 review panels. Median 510(k) review time: 50 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 |
|---|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 9 | 9 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 2 | 2 |
| BTC | Bag, Reservoir | 1 | 1 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 1 | 1 |
| BZA | Connector, Airway (Extension) | 1 | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
| NHK | Resuscitator, Manual, Non Self-Inflating | 1 | 1 |
Review panels
- Anesthesiology (16)
- General Hospital (1)
Most recent Med-Plastics Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K946209 | DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME | BYD | 1995-06-08 | 169 |
| K942572 | VOLUME VENTILATOR | BZO | 1994-06-10 | 10 |
| K942571 | HYPER-INFLATION BAG | NHK | 1994-06-10 | 10 |
| K942570 | MAPLESON D CIRCUIT | CAI | 1994-06-10 | 10 |
| K942569 | VENTILATOR HOSE | BZO | 1994-06-10 | 10 |
| K942568 | ADULT ANESTHESIA BREATHING CIRCUIT | CAI | 1994-06-10 | 10 |
| K942567 | MASS SPECTROMETRY MONITORING LINES AND CONNECTORS | CCK | 1994-06-10 | 10 |
| K932578 | ADULT GAS SAMPLING CIRCUITS | CAI | 1993-07-22 | 56 |
| K932577 | PEDIATRIC GAS SAMPLING | CAI | 1993-07-22 | 56 |
| K932576 | PEDIATRIC TEMPERATURE MONITORING CIRCUITS | CAI | 1993-07-22 | 56 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Med-Plastics Intl., 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 Med-Plastics Intl., Inc. have?
Med-Plastics Intl., Inc. has 17 FDA 510(k) clearances (first 1993, latest 1995), across 8 product codes in 2 review panels.
How long does FDA take to clear Med-Plastics Intl., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Med-Plastics Intl., Inc.'s cleared 510(k)s is 50 days.
What devices does Med-Plastics Intl., Inc. make?
Its most frequent FDA product codes are CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece), 9); BZO (Set, Tubing And Support, Ventilator (W Harness), 2); BTC (Bag, Reservoir, 1).
Has Med-Plastics Intl., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Med-Plastics Intl., Inc. Related entities may recall under other names.
Next steps
- See all 17 Med-Plastics Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAI, Med-Plastics Intl., 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.