510(k) · Cleared
ClearedProcedur SF Safety Syringe Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avanca Medical Devices, Inc. · MEG Syringe, Antistick
Cleared on Jan 21, 2005 as substantially equivalent to K980987 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1998) and 1 other predicate after a 130-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Jan 21, 2005
- Review
- 130 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K980069 (1998). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK980069 Vanishpoint SyringeRetractable Technologies, Inc. · 1998
- This deviceK042487 Procedur SF Safety Syringe DeviceAvanca Medical Devices, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980069 | Vanishpoint Syringe | Retractable Technologies, Inc. | 1998 | — |
| 0 (this device) | K042487 | Procedur SF Safety Syringe Device | Avanca Medical Devices, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 |
|---|---|---|---|
| * | K980987 | Becton Dickinson SyringeSummary page 1…21 CFR 880.5860/Procode 0d FMF/Ad MEG Substantial Equivalence: Becton Dickinson Single Use Hypodermic Syringes (K980987) and Retractable Technologies, Inc. VanishPoint Safety Syringe… | 1998 |
| * | K980069 | Vanishpoint SyringeSummary page 1…Syringes (K980987) and Retractable Technologies, Inc. VanishPoint Safety Syringe (K980069) Device Description: The Procedur-SF device is a piston safety syringe Intend… | 1998 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 17 other devices also cite its predicate K980987.
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 Procedur-SF device is used to inject fluids into,
or withdraw fluids from, the body, while reducing the
risk of sharps injuries and the potential for syringe
reuse.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042487 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042487: Procedur SF Safety Syringe Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042487
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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