510(k) · Cleared
ClearedUltrasafe Passive X-Series, Needle Guard Syringe, Piston (Accessory)
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 May 29, 2001 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- May 29, 2001
- Review
- 25 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK011369 Ultrasafe Passive X-Series, Needle Guard Syringe, Piston (Accessory)Safety Syringes, Inc. · 2001
- Descendant · cites it directly · 4 of its ownK122558 Ultrasafe Passive Needle GuardSafety Syringes, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK123743 Ultrasafe Plus Passive Needle GuardSafety Syringes, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK141464 Novaguard S a Safety SystemWest Pharmaceutical Services · 2014
- Descendant · 2 generations on · 0 of its ownK230287 SaviSafe Safety DeviceSuzhou Savicred Biotechnology Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK163511 NovaGuard SA Pro Safety SystemWest Pharmaceutical Services, Inc. · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K122558Ultrasafe Passive Needle GuardSafety Syringes, Inc. · 2012 · cites it directly4descendants
- K123743Ultrasafe Plus Passive Needle GuardSafety Syringes, Inc. · 2013 · cites it directly3descendants
- K141464Novaguard S a Safety SystemWest Pharmaceutical Services · 2014 · 2 generations on1descendant
- K230287SaviSafe Safety DeviceSuzhou Savicred Biotechnology Co., Ltd. · 2023 · 2 generations on0descendants
- K163511NovaGuard SA Pro Safety SystemWest Pharmaceutical Services, Inc. · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011369 | Ultrasafe Passive X-Series, Needle Guard Syringe, Piston (Accessory) | Safety Syringes, Inc. | 2001 | — |
| +1 | K122558 | Ultrasafe Passive Needle Guard | Safety Syringes, Inc. | 2012 | — |
| +1 | K123743 | Ultrasafe Plus Passive Needle Guard | Safety Syringes, Inc. | 2013 | — |
| +2 | K141464 | Novaguard S a Safety System | West Pharmaceutical Services | 2014 | — |
| +2 | K230287 | SaviSafe Safety Device | Suzhou Savicred Biotechnology Co., Ltd. | 2023 | — |
| +3 | K163511 | NovaGuard SA Pro Safety System | West Pharmaceutical Services, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
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, K122558 (Safety Syringes, Inc., 2012) has gone furthest, with 4 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/K011369 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011369: Ultrasafe Passive X-Series, Needle Guard Syringe, Piston (Accessory).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011369
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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