510(k) · Cleared
ClearedUltrasafe Aspirating Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Safety Syringes, Inc. · MEG Syringe, Antistick
Cleared on Jan 26, 1995 after a 136-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jan 26, 1995
- Review
- 136 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK944425 Ultrasafe Aspirating SyringeSafety Syringes, Inc. · 1995
- Descendant · cites it directly · 0 of its ownK972877 Ultrasafe Injection System Model C200 Injector with Needle GuardSafety Syringes, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK972900 Ultrasafe Model T200 InjectorSafety Syringes, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK972878 Ultrasafe Injection System Needle Guard, Models B50,B100L,B150,B225…Safety Syringes, Inc. · 1997
Most influential descendants
Showing 3 of 3 · See all- K972877Ultrasafe Injection System Model C200 Injector with Needle GuardSafety Syringes, Inc. · 1998 · cites it directly0descendants
- K972900Ultrasafe Model T200 InjectorSafety Syringes, Inc. · 1998 · cites it directly0descendants
- K972878Ultrasafe Injection System Needle Guard, Models B50,B100L,B150,B225, and B300Safety Syringes, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944425 | Ultrasafe Aspirating Syringe | Safety Syringes, Inc. | 1995 | — |
| +1 | K972877 | Ultrasafe Injection System Model C200 Injector with Needle Guard | Safety Syringes, Inc. | 1998 | — |
| +1 | K972900 | Ultrasafe Model T200 Injector | Safety Syringes, Inc. | 1998 | — |
| +1 | K972878 | Ultrasafe Injection System Needle Guard, Models B50,B100L,B150,B225, and B300 | Safety Syringes, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 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? (3)
3 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, K972877 (Safety Syringes, Inc., 1998) 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/K944425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K944425: Ultrasafe Aspirating Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944425
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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