Advanced Infusion, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Advanced Infusion, Inc.” (first 1999, latest 2008), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 74 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 |
|---|---|---|---|
| MEB | Pump, Infusion, Elastomeric | 5 | 5 |
| MED | Sterilant, Medical Devices | 1 | 1 |
Review panels
- General Hospital (6)
Most recent Advanced Infusion, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071532 | ALPHA INFUSION PUMP, MODEL A200, A450 | MEB | 2008-02-19 | 259 |
| K061661 | STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20 | MEB | 2006-10-18 | 127 |
| K061356 | POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6 | MED | 2006-07-03 | 49 |
| K042246 | MULTI-DRIP INFUSION CATHETER | MEB | 2004-08-31 | 12 |
| K021964 | ALPHA INFUSION PUMP AND CATHETERS | MEB | 2002-08-12 | 59 |
| K992551 | ALPHA INFUSION PUMP | MEB | 1999-10-27 | 89 |
Recalls
openFDA lists no recalls under a recalling firm named Advanced Infusion, 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 Advanced Infusion, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via MEB)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MEB)
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.
- Advanced Cardiovascular Systems, Inc. (103 510(k)s)
- Advanced Surgical Products, Inc. (64 510(k)s)
- Advanced Technology Laboratories, Inc. (61 510(k)s)
- Advanced Sterilization Products (59 510(k)s)
- Advanced Neuromodulation Systems (25 510(k)s)
- Advanced Orthopaedic Solutions, Inc. (24 510(k)s)
- Advanced Medical Solutions, Ltd. (22 510(k)s)
- Advanced Biosearch Assn. (22 510(k)s)
- Advanced Biomedical Methods, Inc. (21 510(k)s)
- Advanced Surgical, Inc. (21 510(k)s)
- Advanced Clinical Diagnostics (19 510(k)s)
- Advanced Instrumentations, Inc. (16 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Advanced Infusion, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Advanced Infusion, Inc.” (first 1999, latest 2008), across 2 product codes 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 Advanced Infusion, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Advanced Infusion, Inc. is 74 days.
Which FDA product codes appear under Advanced Infusion, Inc.?
The most frequent FDA product codes under this applicant name are MEB (Pump, Infusion, Elastomeric, 5); MED (Sterilant, Medical Devices, 1).
Next steps
- See all 6 Advanced Infusion, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MEB, Advanced Infusion, 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.