Univec, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Univec, Inc.” (first 1994, latest 2002), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 93 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 |
|---|---|---|---|
| FMF | Syringe, Piston | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| MEG | Syringe, Antistick | 2 | 2 |
| SCL | Allergen And Vaccine Delivery Needles | 1 | 1 |
Review panels
- General Hospital (7)
Most recent Univec, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K020500 | UNIVEC BIFURCATED SLIDING SHEATH SYRINGE | SCL | 2002-03-19 | 33 |
| K993996 | UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE | MEG | 2000-07-17 | 236 |
| K000747 | UNIVEC TWO PIECE SYRINGE | FMF | 2000-06-08 | 93 |
| K961877 | PISTON SYRINGE | FMI | 1996-08-07 | 89 |
| K933469 | UNIVEC NON-REUSABLE SYRINGE | MEG | 1996-04-18 | 1007 |
| K951619 | UNIVEC NONREUSABLE LOCKING SYRINGE | FMF | 1995-06-06 | 71 |
| K943679 | UNIVEC NONRESUSABLE LOCKING SYRINGE | FMI | 1994-12-12 | 139 |
Recalls
openFDA lists no recalls under a recalling firm named Univec, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Univec, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Univec, Inc.” (first 1994, latest 2002), across 4 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 Univec, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Univec, Inc. is 93 days.
Which FDA product codes appear under Univec, Inc.?
The most frequent FDA product codes under this applicant name are FMF (Syringe, Piston, 2); FMI (Needle, Hypodermic, Single Lumen, 2); MEG (Syringe, Antistick, 2).
Next steps
- See all 7 Univec, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMF, Univec, 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.