3M Avi, Inc.: FDA clearances and approvals
3M Avi, Inc. has 18 FDA 510(k) clearances (first 1990, latest 1993), across 2 product codes in 1 review panel. Median 510(k) review time: 28 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 |
|---|---|---|---|
| FRN | Pump, Infusion | 16 | 16 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
Review panels
- General Hospital (18)
Most recent 3M Avi, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K912069 | AVI MODEL 4225 VENTED PIGGYBACK IV ADMIN SET | FPA | 1993-10-14 | 888 |
| K912590 | AVI MODEL 400D INFUSION PUMP | FRN | 1991-10-17 | 129 |
| K912589 | AVI MODEL 840D DUAL CHANNEL INFUSION PUMP | FRN | 1991-10-17 | 129 |
| K912591 | AVI MICRO 210D INFUSION PUMP | FRN | 1991-09-06 | 88 |
| K912875 | AVI MODEL 270CI INFUSION PUMP | FRN | 1991-08-20 | 50 |
| K912738 | AVI VOLUMETRIC INFUSION PUMPS-VARIOUS MODELS | FRN | 1991-08-12 | 52 |
| K912031 | AVI MODEL 870 DUAL CHANNEL INFUSION PUMP | FRN | 1991-06-18 | 41 |
| K904979 | AVI MODEL 600 SYRINGE PUMP, MODIFICATION | FRN | 1991-01-15 | 76 |
| K902858 | AVI MODEL 4206 MANIFOLD CHECKVALVE IV ADMIN. SET | FPA | 1990-12-14 | 168 |
| K903787 | AVI MODEL 470CM INFUSION PUMP | FRN | 1990-09-05 | 16 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named 3M Avi, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of 3M Avi, Inc.'s product codes (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 does 3M Avi, Inc. have?
3M Avi, Inc. has 18 FDA 510(k) clearances (first 1990, latest 1993), across 2 product codes in 1 review panel.
How long does FDA take to clear 3M Avi, Inc.'s 510(k)s?
The median time from FDA receipt to decision across 3M Avi, Inc.'s cleared 510(k)s is 28 days.
What devices does 3M Avi, Inc. make?
Its most frequent FDA product codes are FRN (Pump, Infusion, 16); FPA (Set, Administration, Intravascular, 2).
Has 3M Avi, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching 3M Avi, Inc. Related entities may recall under other names.
Next steps
- See all 18 3M Avi, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRN, 3M Avi, 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.