Amici, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Amici, Inc.” (first 1987, latest 2007), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 152 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 |
|---|---|---|---|
| IYT | System, Rebreathing, Radionuclide | 5 | 5 |
| CAF | Nebulizer (Direct Patient Interface) | 3 | 3 |
Review panels
- Radiology (5)
- Anesthesiology (3)
Most recent Amici, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K063716 | AEROSOL SYSTEM | CAF | 2007-12-28 | 379 |
| K952910 | THE SWIRLER NEBULIZER | CAF | 1997-03-19 | 632 |
| K952893 | THE SWIRLER AEROSOL SYSTEM | CAF | 1995-11-03 | 133 |
| K904684 | AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION | IYT | 1991-01-14 | 152 |
| K903805 | AMICI XENON ADMINISTRATION SET | IYT | 1991-01-14 | 152 |
| K903694 | AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE | IYT | 1990-10-03 | 49 |
| K872920 | AMICI KRYPTON ADMINISTRATION SYSTEM* | IYT | 1988-02-12 | 200 |
| K865084 | AMICI XENON REBREATHING SYSTEM* | IYT | 1987-03-03 | 63 |
Recalls
openFDA lists no recalls under a recalling firm named Amici, 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 Amici, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Amici, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Amici, Inc.” (first 1987, latest 2007), across 2 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 Amici, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Amici, Inc. is 152 days.
Which FDA product codes appear under Amici, Inc.?
The most frequent FDA product codes under this applicant name are IYT (System, Rebreathing, Radionuclide, 5); CAF (Nebulizer (Direct Patient Interface), 3).
Next steps
- See all 8 Amici, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYT, Amici, 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.