510(k) · Cleared
ClearedModification to: Tamper Evident Ultrasafe Passive Delivery System, Ultrasafe Passive Delivery System (X-Series)
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 Apr 28, 2006 after a 39-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- Apr 28, 2006
- Review
- 39 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 4 citing it directly.
- This deviceK060743 Modification to: Tamper Evident Ultrasafe Passive Delivery System…Safety Syringes, Inc. · 2006
- Descendant · cites it directly · 5 of its ownK101233 Safe'n'sound Passive Delivery SystemRexam Pharma · 2011
- 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 ownK141664 Safe'n'sound Staked Passive Delivery System - Cone VersionRexam Healthcare · 2014
- Descendant · 2 generations on · 1 of its ownK141464 Novaguard S a Safety SystemWest Pharmaceutical Services · 2014
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K101233Safe'n'sound Passive Delivery SystemRexam Pharma · 2011 · cites it directly5descendants
- K122558Ultrasafe Passive Needle GuardSafety Syringes, Inc. · 2012 · cites it directly4descendants
- K123743Ultrasafe Plus Passive Needle GuardSafety Syringes, Inc. · 2013 · cites it directly3descendants
- K141664Safe'n'sound Staked Passive Delivery System - Cone VersionRexam Healthcare · 2014 · 2 generations on1descendant
- K141464Novaguard S a Safety SystemWest Pharmaceutical Services · 2014 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060743 | Modification to: Tamper Evident Ultrasafe Passive Delivery System, Ultrasafe… | Safety Syringes, Inc. | 2006 | — |
| +1 | K101233 | Safe'n'sound Passive Delivery System | Rexam Pharma | 2011 | — |
| +1 | K122558 | Ultrasafe Passive Needle Guard | Safety Syringes, Inc. | 2012 | — |
| +1 | K123743 | Ultrasafe Plus Passive Needle Guard | Safety Syringes, Inc. | 2013 | — |
| +2 | K141664 | Safe'n'sound Staked Passive Delivery System - Cone Version | Rexam Healthcare | 2014 | — |
| +2 | K141464 | Novaguard S a Safety System | West Pharmaceutical Services | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | — | Tamper Evident UltraSafe® Passive™ Delivery System Named without a submission number | |
| * | — | UltraSafe® Passive™ Delivery System (X-Series) Named without a submission number |
What descends from it? (9)
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, K101233 (Rexam Pharma, 2011) has gone furthest, with 5 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 | — |
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 needlesticks The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration. Single use devices that are…
Read the full statement (114 words)
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 needlesticks
The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.
Single use devices that are indicated for use as an accessory with pre-filled ISO Standard glass syringes to bid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications, and individuals that assist self-injecting patients, from accidental needlesticks.
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/K060743 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060743: Modification to: Tamper Evident Ultrasafe Passive Delivery System, Ultrasafe Passive Delivery System (X-Series).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060743
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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