510(k) · Cleared
ClearedUnivec Bifurcated Sliding Sheath Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Univec, Inc. · SCL Allergen And Vaccine Delivery Needles
Cleared on Mar 19, 2002 after a 33-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 19, 2002
- Review
- 33 days
- Class
- Class II
- Product code
- SCL
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SCL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new SCL device
- #1 K250983 Medblue Skin Prick Test Applicator (AS103…score 11.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All SCL devicesSCL Allergen And Vaccine Delivery Needles: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · SCL
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · SCL
Too few SCL 510(k)s in any year since 2007 to give a median.
Recalls per year · SCL
No recall names SCL since 2007.
Adverse event reports per year · SCL
No MAUDE report names SCL since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Univec Bifurcated Sliding Sheath Syringe is a safety version of a bifurcated needle attached to a syringe barrel with the Univec Sliding Sheath Syringe mechanism. The Univec Sliding Sheath mechanism is used to aid in the prevention of needle stick injuries. This device is used in the same manner as a standard - Bifurcated Needle to deliver vaccine or allergen to the patient.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020500 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020500: Univec Bifurcated Sliding Sheath Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020500
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026