510(k) · Cleared
ClearedOvus Capless Safety Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ovus Systems · MEG Syringe, Antistick
Cleared on Feb 6, 2002 as substantially equivalent to K946219 (Retractable Technologies, Inc., 1995) and 2 other predicates after a 153-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Feb 6, 2002
- Review
- 153 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K904198 (1990). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK904198 Safety Needle SheathConcord/Portex · 1990
- This deviceK013006 Ovus Capless Safety NeedleOvus Systems · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904198 | Safety Needle Sheath | Concord/Portex | 1990 | — |
| 0 (this device) | K013006 | Ovus Capless Safety Needle | Ovus Systems | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 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? (3)
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 |
|---|---|---|---|
| * | K946219 | Pop-N-Lok SyringeSummary page 1…with a standard commercially available syringe, is substantially equivalent to the Retractable Technologies Pop-N-Lok Syringe that was cleared for marketing by FDA under K946219 on December 28, 1995. It is also substantially equivalent to the Needle-Pro needle protection device that is manufactured by Conc… | 1995 |
| * | K904198 | Safety Needle SheathSummary page 1…er 28, 1995. It is also substantially equivalent to the Needle-Pro needle protection device that is manufactured by Concord Portex and cleared for marketing by FDA under K904198 and K911037. B. DEVICE DESCRIPTION The OVUS Capless Safety Needle is a retractable needle system that provides anti-sharps prot… | 1990 |
| * | K911037 | Safety Needle Sheath, ModificationSummary page 1…It is also substantially equivalent to the Needle-Pro needle protection device that is manufactured by Concord Portex and cleared for marketing by FDA under K904198 and K911037. B. DEVICE DESCRIPTION The OVUS Capless Safety Needle is a retractable needle system that provides anti-sharps protection. The… | 1991 |
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 3 ancestors has a recall.
- 4 other devices also cite its predicate K946219.
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?
The OVUS Capless Safety Needle, when used with a standard commerdially available syringe, is intended to inject fluids into, or withdraw fluids from, parts of the body, including the applications of hypodermic injection, veinipuncture, and drawing of arterial blood. The needle is retracted after use to prevent further needle sticks.
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/K013006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013006: Ovus Capless Safety Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013006
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026