510(k) · Cleared
ClearedSafe'n'Sound Staked Passive Delivery System - Plajex version
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nemera · MEG Syringe, Antistick
Cleared on Jun 2, 2015 as substantially equivalent to K141664 (Rexam Healthcare, 2014) after an 88-day review. Its family tree reaches back 3 generations to 2006.
- Decided
- Jun 2, 2015
- Review
- 88 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K060743 (2006). No later device cites it as a predicate yet.
- Root · 3 generations backK060743 Modification to: Tamper Evident Ultrasafe Passive Delivery System…Safety Syringes, Inc. · 2006
- 2 generations backK101233 Safe'n'sound Passive Delivery SystemRexam Pharma · 2011
- 1 generation backK141664 Safe'n'sound Staked Passive Delivery System - Cone VersionRexam Healthcare · 2014
- This deviceK150562 Safe'n'Sound Staked Passive Delivery System - Plajex versionNemera · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K060743 | Modification to: Tamper Evident Ultrasafe Passive Delivery System, Ultrasafe… | Safety Syringes, Inc. | 2006 | — |
| −2 | K101233 | Safe'n'sound Passive Delivery System | Rexam Pharma | 2011 | — |
| −1 | K141664 | Safe'n'sound Staked Passive Delivery System - Cone Version | Rexam Healthcare | 2014 | — |
| 0 (this device) | K150562 | Safe'n'Sound Staked Passive Delivery System - Plajex version | Nemera | 2015 | — |
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 |
|---|---|---|---|
| * | K141664 | Safe'n'sound Staked Passive Delivery System - Cone VersionSummary page 4…Classification Name: Piston syringe Classification/Product Code: 21 CFR 880.5860, Class II, Product Code MEG Predicate Device: K141664 Safe’n’Sound® Passive Delivery System – Cone version by Nemera Device Description: This sub… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 prefilled ISO Standard plastic 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 intended patient population is unrestricted and may include children and adults, for parenteral methods of administration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150562 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150562: Safe'n'Sound Staked Passive Delivery System - Plajex version.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150562
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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