510(k) · Cleared
ClearedUnivec Non-Reusable Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Univec, Inc. · MEG Syringe, Antistick
Cleared on Apr 18, 1996 as substantially equivalent to K943679 (Univec, Inc., 1994) and 1 other predicate after a 1,007-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Apr 18, 1996
- Review
- 1,007 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K891467 (1989). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK891467 Lokshot Piston SyringeFlp Ent., Inc. · 1989
- This deviceK933469 Univec Non-Reusable SyringeUnivec, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891467 | Lokshot Piston Syringe | Flp Ent., Inc. | 1989 | — |
| 0 (this device) | K933469 | Univec Non-Reusable Syringe | Univec, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MEG? 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 MEG device
- #1 K192551 1ml Luer Slip or Luer Lock Syringe, Syringe…score 19.6 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K943679 | Univec Nonresusable Locking Syringe Cleared while this submission was under review Summary page 1…,tpes: Piston Syringe : 21 C.F.R. 880.5800 Class Il Hypodermic Single Lumen Needle 21 CF.R.880.5570 Class Il (3) Predicate Devices: UNIVEC Nonreusable Locking Sytinge (K943679) FLP Enterprises LOKSHOT Syringe (K891467) (4) Description of Device: The UNIVEC Model 884 Unibrella Nonreusable Syringe is a ste… | 1994 |
| * | K891467 | Lokshot Piston SyringeSummary page 1…Class Il Hypodermic Single Lumen Needle 21 CF.R.880.5570 Class Il (3) Predicate Devices: UNIVEC Nonreusable Locking Sytinge (K943679) FLP Enterprises LOKSHOT Syringe (K891467) (4) Description of Device: The UNIVEC Model 884 Unibrella Nonreusable Syringe is a sterile piston syringe with 1 cc or 0.5 cc ca… | 1989 |
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.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K943679.
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEG
229in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEG
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MEG
148in 2025
MAUDE reports naming product code MEG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 100 | 0 | 21 |
| 2008 | 4 | 145 | 1 | 20 |
| 2009 | 2 | — | 0 | 26 |
| 2010 | 2 | — | 1 | 34 |
| 2011 | 5 | 113 | 0 | 34 |
| 2012 | 5 | 109 | 0 | 22 |
| 2013 | 1 | — | 5 | 27 |
| 2014 | 5 | 153 | 0 | 36 |
| 2015 | 7 | 253 | 1 | 51 |
| 2016 | 3 | 179 | 0 | 94 |
| 2017 | 3 | 130 | 0 | 181 |
| 2018 | 1 | — | 0 | 269 |
| 2019 | 4 | 249 | 0 | 497 |
| 2020 | 4 | 296 | 0 | 353 |
| 2021 | 5 | 152 | 0 | 541 |
| 2022 | 13 | 216 | 0 | 170 |
| 2023 | 5 | 229 | 0 | 120 |
| 2024 | 0 | — | 1 (1) | 112 |
| 2025 | 1 | — | 0 | 148 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
This syringe is intended for diabetics who inject insulin and healthcare professionals who inject insulin, tuberculin or immunization serum and other injectible medications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K933469 · printed Nov 5, 2026
Cite this page
510(k) Report. “K933469: Univec Non-Reusable Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K933469
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026