510(k) · Cleared
ClearedSafesnap Safety Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U.S. Medical Instruments, Inc. · MEG Syringe, Antistick
Cleared on Feb 16, 1994 after a 499-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Feb 16, 1994
- Review
- 499 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK925039 Safesnap Safety SyringeU.S. Medical Instruments, Inc. · 1994
- Descendant · cites it directly · 0 of its ownK031065 Syringex Safety Syringe, Model 0322G1.5Syringex Medical, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK991039 Easysafe Retracting Needle SyringeSaf-T-Med, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK973792 Easysafe Retracting Needle SyringeSaf-T-Med, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK953940 Terumo Retractable Needle (RN) SyringeTerumo Medical Corp. · 1996
Most influential descendants
Showing 4 of 4 · See all- K031065Syringex Safety Syringe, Model 0322G1.5Syringex Medical, Inc. · 2003 · cites it directly0descendants
- K991039Easysafe Retracting Needle SyringeSaf-T-Med, Inc. · 1999 · cites it directly0descendants
- K973792Easysafe Retracting Needle SyringeSaf-T-Med, Inc. · 1998 · cites it directly0descendants
- K953940Terumo Retractable Needle (RN) SyringeTerumo Medical Corp. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925039 | Safesnap Safety Syringe | U.S. Medical Instruments, Inc. | 1994 | — |
| +1 | K031065 | Syringex Safety Syringe, Model 0322G1.5 | Syringex Medical, Inc. | 2003 | — |
| +1 | K991039 | Easysafe Retracting Needle Syringe | Saf-T-Med, Inc. | 1999 | — |
| +1 | K973792 | Easysafe Retracting Needle Syringe | Saf-T-Med, Inc. | 1998 | — |
| +1 | K953940 | Terumo Retractable Needle (RN) Syringe | Terumo Medical Corp. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K031065 (Syringex Medical, Inc., 2003) has gone furthest, with 0 descendants of its own.
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 | — |
https://510kreport.com/device/K925039 · printed Nov 5, 2026
Cite this page
510(k) Report. “K925039: Safesnap Safety Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K925039
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026