510(k) · Cleared
ClearedSafe'n'sound Staked Passive Delivery System - Cone Version
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rexam Healthcare · MEG Syringe, Antistick
Cleared on Oct 2, 2014 as substantially equivalent to K101233 (Rexam Pharma, 2011) after a 101-day review. Its family tree reaches back 2 generations to 2006. 1 later device descends from it.
- Decided
- Oct 2, 2014
- Review
- 101 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K060743 (2006). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK060743 Modification to: Tamper Evident Ultrasafe Passive Delivery System…Safety Syringes, Inc. · 2006
- 1 generation backK101233 Safe'n'sound Passive Delivery SystemRexam Pharma · 2011
- This deviceK141664 Safe'n'sound Staked Passive Delivery System - Cone VersionRexam Healthcare · 2014
- Descendant · cites it directly · 0 of its ownK150562 Safe'n'Sound Staked Passive Delivery System - Plajex versionNemera · 2015
Most influential descendants
Showing 1 of 1 · See all- K150562Safe'n'Sound Staked Passive Delivery System - Plajex versionNemera · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K141664 | Safe'n'sound Staked Passive Delivery System - Cone Version | Rexam Healthcare | 2014 | — |
| +1 | K150562 | Safe'n'Sound Staked Passive Delivery System - Plajex version | Nemera | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K101233 | Safe'n'sound Passive Delivery SystemSummary page 4…tion Name: Antistick piston syringe accessory Classification/Product Code: 21 CFR 880.5860, Class II, Product Code MEG Predicate Device: K101233 Safe’n’Sound® Passive Delivery System by Rexam Healthcare Device Description: This… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150562 | Safe'n'Sound Staked Passive Delivery System - Plajex version | 2015 | 0 |
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. 2014, 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 device that is 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 needle sticks. 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/K141664 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141664: Safe'n'sound Staked Passive Delivery System - Cone Version.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141664
Report an extraction error
Are you the manufacturer?
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