Zevex, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Zevex, Inc.” (first 2001, latest 2024), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 121 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 | 1 | 294 |
| 2015 | 1 | 121 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 139 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Zevex, Inc. took a median 139 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 174 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRN | Pump, Infusion | 2 | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
| LZH | Pump, Infusion, Enteral | 1 | 1 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | 1 | 1 |
Review panels
Most recent Zevex, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242660 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets | FRN | 2024-10-03 | 29 |
| K232793 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets | FRN | 2024-05-17 | 249 |
| K142539 | EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set | PIF | 2015-01-08 | 121 |
| K131154 | ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET; | LZH | 2014-02-12 | 294 |
| K012147 | DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE | KNT | 2001-11-02 | 115 |
Recalls
openFDA lists no recalls under a recalling firm named Zevex, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Zevex, Inc. (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)
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.
- Zevex Intl., Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zevex, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Zevex, Inc.” (first 2001, latest 2024), 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 Zevex, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zevex, Inc. is 121 days.
Which FDA product codes appear under Zevex, Inc.?
The most frequent FDA product codes under this applicant name are FRN (Pump, Infusion, 2); KNT (Tubes, Gastrointestinal (And Accessories), 1); LZH (Pump, Infusion, Enteral, 1).
Next steps
- See all 5 Zevex, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRN, Zevex, 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.