Corpak Co.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Corpak Co.” (first 1981, latest 1998), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 54 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) | 10 | 10 |
| CAF | Nebulizer (Direct Patient Interface) | 3 | 3 |
| FRN | Pump, Infusion | 3 | 3 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 2 | 2 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 2 | 2 |
| FKO | Catheter, Peritoneal Dialysis, Single Use | 1 | 1 |
| KGC | Tube, Gastro-Enterostomy | 1 | 1 |
| KOD | Catheter, Urological | 1 | 1 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 1 | 1 |
Review panels
Most recent Corpak Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964514 | CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS | FKO | 1998-06-26 | 605 |
| K970178 | CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM | KNT | 1997-07-21 | 185 |
| K935512 | CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE | KNT | 1996-08-29 | 1017 |
| K944750 | CORFLO 300 PUMP | FRN | 1995-06-19 | 266 |
| K931921 | CORPAK GASTROSTOMY TUBE | KNT | 1995-06-09 | 784 |
| K932847 | CORPAK ENTERAL PUMP | FRN | 1994-06-17 | 372 |
| K902949 | CORPAK GRASPING FORCEPS | OCZ | 1990-08-30 | 56 |
| K901501 | CORPAK GASTROSTOMY TUBE | KGC | 1990-06-11 | 73 |
| K882867 | CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE | KNT | 1988-09-21 | 72 |
| K853253 | CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELI | KNT | 1985-11-05 | 95 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Corpak Co..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Corpak Co. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
- G0379 — Direct admission of patient for hospital observation care (via CAF)
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 Medsystems (15 510(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 Co.?
FDA lists 24 510(k) clearances under the applicant name “Corpak Co.” (first 1981, latest 1998), across 9 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 Corpak Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Corpak Co. is 54 days.
Which FDA product codes appear under Corpak Co.?
The most frequent FDA product codes under this applicant name are KNT (Tubes, Gastrointestinal (And Accessories), 10); CAF (Nebulizer (Direct Patient Interface), 3); FRN (Pump, Infusion, 3).
Next steps
- See all 24 Corpak Co. clearances with predicates and recalls
- Run predicate analysis for product code KNT, Corpak Co.'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.