510(k) · Cleared
ClearedMiramatic Safe Syringe System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hager Worldwide, Inc. · EJI Syringe, Cartridge
Cleared on Jul 21, 2005 as substantially equivalent to K022959 (MDC Research, Ltd., 2003) after a 231-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Jul 21, 2005
- Review
- 231 days
- Class
- Class II
- Product code
- EJI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K913573 (1991). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 EJI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K022959 | Safestep Safety Dental Cartridge Injector, Model 33-00000-1Summary page 1…yringe 872 4730, DZNI Dental Needle Predicate Devices SafeStepTMd Safety Dental Cartridge Injector K022959 ("I -ShotTM I Safety Syringe ") Dental needles are 510(k) exempt. Modifications The device em… | 2003 |
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 14 years and passes through 3 companies; a new generation was cleared every 11.2 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All EJI devicesEJI Syringe, Cartridge: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EJI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · EJI
78in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EJI
No recall names EJI since 2007.
Adverse event reports per year · EJI
1in 2025
MAUDE reports naming product code EJI, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 3 | 78 | 0 | 3 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 2 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Indicated for use with pre-filled anesthetic cartridges and press fit dental needles for the manual injection of local dental anesthetics into the oral tissues.
The cartridge syringe may aid in the reduction of needle stick injuries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043322 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043322: Miramatic Safe Syringe System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043322
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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