Pacific Device, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Pacific Device, Inc.” (first 1990, latest 1997), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 62 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 |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | 2 | 2 |
| BSY | Catheters, Suction, Tracheobronchial | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| KPE | Container, I.V. | 1 | 1 |
Review panels
- General Hospital (4)
- Anesthesiology (1)
Most recent Pacific Device, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972464 | VITALMIX PLUS EMPTY I.V. CONTAINER | KPE | 1997-11-05 | 127 |
| K923782 | TRANSFER SET | LHI | 1993-07-02 | 339 |
| K912860 | INTRAVASCULAR ADMINISTRATION SETS | FPA | 1991-08-28 | 62 |
| K912596 | MECONIUM ASPIRATION | BSY | 1991-07-30 | 50 |
| K902482 | VITALMIX (SET & BAG) | LHI | 1990-07-02 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named Pacific Device, 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.
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.
- Pacific Biotech, Inc. (29 510(k)s)
- Pacific Hemostasis (29 510(k)s)
- Pacific Dental Corp. (22 510(k)s)
- Pacific Union Dental, Inc. (5 510(k)s)
- Pacific Consolidated Industries, LLC (4 510(k)s)
- Pacific Materials and Interfaces (3 510(k)s)
- Pacific Andrology, Inc. (2 510(k)s)
- Pacific Consolidated Industries Llp (2 510(k)s)
- Pacific Delta Medical Supply (2 510(k)s)
- Pacific Implant, Inc. (2 510(k)s)
- Pacific Medico Co., Ltd. (2 510(k)s)
- Pacific Rim Dental, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pacific Device, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Pacific Device, Inc.” (first 1990, latest 1997), 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 Pacific Device, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pacific Device, Inc. is 62 days.
Which FDA product codes appear under Pacific Device, Inc.?
The most frequent FDA product codes under this applicant name are LHI (Set, I.V. Fluid Transfer, 2); BSY (Catheters, Suction, Tracheobronchial, 1); FPA (Set, Administration, Intravascular, 1).
Next steps
- See all 5 Pacific Device, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LHI, Pacific Device, 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.