510(k) · Cleared
ClearedAspiject Self-Aspirating Dental Injection Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ronvig Instruments, Ltd. · EJI Syringe, Cartridge
Cleared on Oct 13, 2000 after an 88-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Oct 13, 2000
- Review
- 88 days
- Class
- Class II
- Product code
- EJI
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK002168 Aspiject Self-Aspirating Dental Injection SyringeRonvig Instruments, Ltd. · 2000
- Descendant · cites it directly · 3 of its ownK040671 Eroject, Miniject, Self Aspirating Syringes, Aspirating Syringes…Anthogyr · 2004
- Descendant · 2 generations on · 2 of its ownK083796 Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex…Miltex, Inc. · 2009
- Descendant · 3 generations on · 0 of its ownK171254 LeEject 2 Dental Syringe and Needle SystemAdvanced Technology and Capital, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK092943 Aspirating Syringe, Non-Aspirating SyringeArnold Tuber Industries · 2009
Most influential descendants
Showing 4 of 4 · See all- K040671Eroject, Miniject, Self Aspirating Syringes, Aspirating Syringes, Non Aspirating SyringesAnthogyr · 2004 · cites it directly3descendants
- K083796Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex Self-Aspirating…Miltex, Inc. · 2009 · 2 generations on2descendants
- K171254LeEject 2 Dental Syringe and Needle SystemAdvanced Technology and Capital, Inc. · 2017 · 3 generations on0descendants
- K092943Aspirating Syringe, Non-Aspirating SyringeArnold Tuber Industries · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002168 | Aspiject Self-Aspirating Dental Injection Syringe | Ronvig Instruments, Ltd. | 2000 | — |
| +1 | K040671 | Eroject, Miniject, Self Aspirating Syringes, Aspirating Syringes, Non… | Anthogyr | 2004 | — |
| +2 | K083796 | Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex… | Miltex, Inc. | 2009 | — |
| +3 | K171254 | LeEject 2 Dental Syringe and Needle System | Advanced Technology and Capital, Inc. | 2017 | — |
| +2 | K092943 | Aspirating Syringe, Non-Aspirating Syringe | Arnold Tuber Industries | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 2 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040671 | Eroject, Miniject, Self Aspirating Syringes, Aspirating Syringes, Non Aspirating Syringes | 2004 | 3 |
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, K040671 (Anthogyr, 2004) has gone furthest, with 3 descendants of its own.
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 | — |
https://510kreport.com/device/K002168 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002168: Aspiject Self-Aspirating Dental Injection Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002168
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026