Corpak Medsystems: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Corpak Medsystems” (first 1982, latest 2014), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 76 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 | 1 | 57 |
| 2013 | 1 | 76 |
| 2014 | 2 | 120 |
| 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) | 9 | 9 |
| FPD | Tube, Feeding | 4 | 4 |
| OMF | Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position | 1 | 1 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | 1 | 1 |
Review panels
Most recent Corpak Medsystems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142012 | FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS | PIF | 2014-11-20 | 119 |
| K133599 | CORGRIP | KNT | 2014-03-26 | 121 |
| K131532 | ELECTROMAGNETIC TRANSMITTING STYLET | KNT | 2013-08-12 | 76 |
| K113351 | CORTRAK ENTERAL ACCESS DEVICE | KNT | 2012-01-10 | 57 |
| K100365 | FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV | KNT | 2010-05-20 | 97 |
| K091637 | CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 | KNT | 2009-09-29 | 117 |
| K083776 | CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S | FPD | 2009-03-05 | 76 |
| K083791 | CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S | FPD | 2009-03-04 | 75 |
| K083786 | CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND 20-1030AIV-LB | FPD | 2009-02-20 | 63 |
| K083121 | NEO MAPCATH SENSOR STYLET | OMF | 2009-02-11 | 112 |
5 earlier clearances. See the full list in Caduvo.
Recalls
4 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2017-02-03.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Corpak Co. (24 510(k)s)
- Corpak Medsystems, Inc. A Division of Haylard Health (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Corpak Medsystems?
FDA lists 15 510(k) clearances under the applicant name “Corpak Medsystems” (first 1982, latest 2014), across 4 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 Corpak Medsystems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Corpak Medsystems is 76 days.
Which FDA product codes appear under Corpak Medsystems?
The most frequent FDA product codes under this applicant name are KNT (Tubes, Gastrointestinal (And Accessories), 9); FPD (Tube, Feeding, 4); OMF (Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position, 1).
Next steps
- See all 15 Corpak Medsystems clearances with predicates and recalls
- Run predicate analysis for product code KNT, Corpak Medsystems'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.