510(k) · Cleared
ClearedUltrasafe Passive Needle Guard
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 Sep 20, 2012 as substantially equivalent to K011369 (Safety Syringes, Inc., 2001) and 1 other predicate after a 29-day review. Its family tree reaches back 1 generation to 2001. 4 later devices descend from it.
- Decided
- Sep 20, 2012
- Review
- 29 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K011369 (2001). 2 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK011369 Ultrasafe Passive X-Series, Needle Guard Syringe, Piston (Accessory)Safety Syringes, Inc. · 2001
- This deviceK122558 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
Most influential descendants
Showing 4 of 4 · See all- 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 |
|---|---|---|---|---|---|
| −1 | K011369 | Ultrasafe Passive X-Series, Needle Guard Syringe, Piston (Accessory) | Safety Syringes, Inc. | 2001 | — |
| 0 (this device) | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K011369 | Ultrasafe Passive X-Series, Needle Guard Syringe, Piston (Accessory) | 2001 |
| * | K060743 | Modification to: Tamper Evident Ultrasafe Passive Delivery System, Ultrasafe Passive…Summary page 1…Piston Syringe Classification Number(s)/Product Code(s): 21 CFR 880.5860 (MEG) Legally Marketed Predicate Device: UltraSafe Passive Delivery System (5 10(k) KOI 1369, K060743) Device Description: The SSI UltraSafe Passive Needle Guard (X-Series) is an anti-needlestick accessory for pre-filled ISO stand… | 2006 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123743 | Ultrasafe Plus Passive Needle Guard | 2013 | 3 |
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?
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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?
Single use devices that are indicated for use as an accessory with pre-filled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications and individuals that assist self-injecting patients, from accidental neediesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122558 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122558: Ultrasafe Passive Needle Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122558
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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