510(k) · Cleared
ClearedSafe'n'sound Passive Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rexam Pharma · MEG Syringe, Antistick
Cleared on Feb 18, 2011 as substantially equivalent to K060743 (Safety Syringes, Inc., 2006) after a 291-day review. Its family tree reaches back 1 generation to 2006. 5 later devices descend from it.
- Decided
- Feb 18, 2011
- Review
- 291 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K060743 (2006). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK060743 Modification to: Tamper Evident Ultrasafe Passive Delivery System…Safety Syringes, Inc. · 2006
- This deviceK101233 Safe'n'sound Passive Delivery SystemRexam Pharma · 2011
- Descendant · cites it directly · 1 of its ownK141664 Safe'n'sound Staked Passive Delivery System - Cone VersionRexam Healthcare · 2014
- Descendant · cites it directly · 1 of its ownK141464 Novaguard S a Safety SystemWest Pharmaceutical Services · 2014
- Descendant · 2 generations on · 0 of its ownK163511 NovaGuard SA Pro Safety SystemWest Pharmaceutical Services, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK150562 Safe'n'Sound Staked Passive Delivery System - Plajex versionNemera · 2015
- Descendant · cites it directly · 0 of its ownK112936 Safe'sound Luer Lock Passive Devlivery SystemRexam Consummer Plastics Inc.D/B/A Rexam Pharma · 2012
Most influential descendants
Showing 5 of 5 · See all- K141664Safe'n'sound Staked Passive Delivery System - Cone VersionRexam Healthcare · 2014 · cites it directly1descendant
- K141464Novaguard S a Safety SystemWest Pharmaceutical Services · 2014 · cites it directly1descendant
- K163511NovaGuard SA Pro Safety SystemWest Pharmaceutical Services, Inc. · 2017 · 2 generations on0descendants
- K150562Safe'n'Sound Staked Passive Delivery System - Plajex versionNemera · 2015 · 2 generations on0descendants
- K112936Safe'sound Luer Lock Passive Devlivery SystemRexam Consummer Plastics Inc.D/B/A Rexam Pharma · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060743 | Modification to: Tamper Evident Ultrasafe Passive Delivery System, Ultrasafe… | Safety Syringes, Inc. | 2006 | — |
| 0 (this device) | K101233 | Safe'n'sound Passive Delivery System | Rexam Pharma | 2011 | — |
| +1 | K141664 | Safe'n'sound Staked Passive Delivery System - Cone Version | Rexam Healthcare | 2014 | — |
| +1 | K141464 | Novaguard S a Safety System | West Pharmaceutical Services | 2014 | — |
| +2 | K163511 | NovaGuard SA Pro Safety System | West Pharmaceutical Services, Inc. | 2017 | — |
| +2 | K150562 | Safe'n'Sound Staked Passive Delivery System - Plajex version | Nemera | 2015 | — |
| +1 | K112936 | Safe'sound Luer Lock Passive Devlivery System | Rexam Consummer Plastics Inc.D/B/A Rexam Pharma | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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? (1)
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 |
|---|---|---|---|
| * | K060743 | Modification to: Tamper Evident Ultrasafe Passive Delivery System, Ultrasafe Passive…Summary page 1…ery System Classification Name: Piston syringe accessory Classification: 21 CFR 880.5860, Class 11, Product Code MEG Predicate Device: K060743 UltraSate Passive Delivery System by Safety Syringes, Inc. Device Description: The Safe'n'… | 2006 |
What descends from it? (5)
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?
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 sterile 1 mL long staked needle prefilled 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 devices can be used on a wide range of patients including children and adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101233: Safe'n'sound Passive Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101233
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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