Facet Technologies: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Facet Technologies” (first 2014, latest 2014), across 1 product code in 1 review panel. Median 510(k) review time under this name: 115 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 |
|---|---|---|
| 2014 | 1 | 115 |
| 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
Review panels
- General Hospital (1)
Most recent Facet Technologies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133100 | CAREFINE PEN NEEDLE | FMI | 2014-01-23 | 115 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2008-07-18.
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.
- Facet Technologies, LLC (7 510(k)s)
- Facet-Link, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Facet Technologies?
FDA lists 1 510(k) clearance under the applicant name “Facet Technologies” (first 2014, latest 2014), 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 Facet Technologies?
The median time from FDA receipt to decision across 510(k)s cleared under the name Facet Technologies is 115 days.
Which FDA product codes appear under Facet Technologies?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 1).
Next steps
- See all 1 Facet Technologies clearances with predicates and recalls
- Run predicate analysis for product code FMI, Facet Technologies'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.