510(k) · Cleared
ClearedEroject, Miniject, Self Aspirating Syringes, Aspirating Syringes, Non Aspirating Syringes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anthogyr · EJI Syringe, Cartridge
Cleared on Dec 14, 2004 as substantially equivalent to K991888 (Spartan Ultrasonics, Inc., 1999) and 1 other predicate after a 274-day review. Its family tree reaches back 2 generations to 1980. 3 later devices descend from it.
- Decided
- Dec 14, 2004
- Review
- 274 days
- Class
- Class II
- Product code
- EJI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K802483 (1980). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK802483 LigmajectAlan J. Khedarri D.D.S., Inc. · 1980
- 1 generation backK991888 MinijectSpartan Ultrasonics, Inc. · 1999
- This deviceK040671 Eroject, Miniject, Self Aspirating Syringes, Aspirating Syringes…Anthogyr · 2004
- Descendant · cites it directly · 2 of its ownK083796 Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex…Miltex, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK171254 LeEject 2 Dental Syringe and Needle SystemAdvanced Technology and Capital, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK092943 Aspirating Syringe, Non-Aspirating SyringeArnold Tuber Industries · 2009
Most influential descendants
Showing 3 of 3 · See all- K083796Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex Self-Aspirating…Miltex, Inc. · 2009 · cites it directly2descendants
- K171254LeEject 2 Dental Syringe and Needle SystemAdvanced Technology and Capital, Inc. · 2017 · 2 generations on0descendants
- K092943Aspirating Syringe, Non-Aspirating SyringeArnold Tuber Industries · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K802483 | Ligmaject | Alan J. Khedarri D.D.S., Inc. | 1980 | — |
| −1 | K991888 | Miniject | Spartan Ultrasonics, Inc. | 1999 | — |
| 0 (this device) | K040671 | Eroject, Miniject, Self Aspirating Syringes, Aspirating Syringes, Non… | Anthogyr | 2004 | — |
| +1 | K083796 | Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex… | Miltex, Inc. | 2009 | — |
| +2 | K171254 | LeEject 2 Dental Syringe and Needle System | Advanced Technology and Capital, Inc. | 2017 | — |
| +1 | K092943 | Aspirating Syringe, Non-Aspirating Syringe | Arnold Tuber Industries | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 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 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? (3)
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 |
|---|---|---|---|
| * | K991888 | MinijectSummary page 2…L EQUIVALENCE ANTHOGYR Devices Predicate devices Ergoject / Miniject intraligamental syringes Minied (Sparan Ultrasonics) K991888 Self aspirating Stainless steel anesthetic Aspiject (Ronvig Instruments) K002168 syringe Stainless steel and… | 1999 |
| * | K002168 | Aspiject Self-Aspirating Dental Injection SyringeSummary page 2…ject / Miniject intraligamental syringes Minied (Sparan Ultrasonics) K991888 Self aspirating Stainless steel anesthetic Aspiject (Ronvig Instruments) K002168 syringe Stainless steel and chrome plated Numerous devices currently on market anesthetic syringes… | 2000 |
| * | — | Cartridge Syringes (Septodont Inc, Ranfac, Cook Waite Kodak, Miltex) Named without a submission number |
What descends from it? (3)
2 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?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 18.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K083796 (Miltex, Inc., 2009) has gone furthest, with 2 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 | — |
What is it indicated for?
ANTHOGYR cartridge syringes are devices intended to inject anesthetic solutions in the oral cavity.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K040671 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040671: Eroject, Miniject, Self Aspirating Syringes, Aspirating Syringes, Non Aspirating Syringes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040671
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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