Avi, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Avi, Inc.” (first 1981, latest 1988), across 1 product code in 1 review panel. Median 510(k) review time under this name: 87 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 |
|---|---|---|---|
| FRN | Pump, Infusion | 13 | 13 |
Review panels
- General Hospital (13)
Most recent Avi, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K882047 | ENTRUST(TM) MODEL 800 | FRN | 1988-08-11 | 87 |
| K875365 | MODEL 200A INFUSION PUMP | FRN | 1988-04-29 | 120 |
| K875348 | MODEL 400A INFUSION PUMP | FRN | 1988-04-29 | 120 |
| K875347 | MODEL 210A INFUSION PUMP | FRN | 1988-04-29 | 120 |
| K872516 | INFUSION PUMP MODEL 275 | FRN | 1987-12-16 | 175 |
| K872515 | INFUSION PUMP MODEL 470 | FRN | 1987-12-16 | 175 |
| K872514 | INFUSION PUMP MODEL 270 | FRN | 1987-12-16 | 175 |
| K854074 | MODEL 200 INFUSION PUMP | FRN | 1985-12-10 | 67 |
| K854073 | MODEL 210 INFUSION PUMP | FRN | 1985-12-10 | 67 |
| K843616 | AVI GUARDIAN 400 INFUSION PUMP | FRN | 1984-10-31 | 47 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Avi, 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 Avi, 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)
Frequently asked questions
How many FDA 510(k) clearances are listed under Avi, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Avi, Inc.” (first 1981, latest 1988), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Avi, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Avi, Inc. is 87 days.
Which FDA product codes appear under Avi, Inc.?
The most frequent FDA product codes under this applicant name are FRN (Pump, Infusion, 13).
Next steps
- See all 13 Avi, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRN, Avi, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.