510(k) · Cleared
ClearedMiniject
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spartan Ultrasonics, Inc. · EJI Syringe, Cartridge
Cleared on Aug 25, 1999 as substantially equivalent to K823536 (Miltex Instrument Co., 1982) and 1 other predicate after an 84-day review. Its family tree reaches back 1 generation to 1980. 4 later devices descend from it.
- Decided
- Aug 25, 1999
- Review
- 84 days
- Class
- Class II
- Product code
- EJI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K802483 (1980). 2 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK802483 LigmajectAlan J. Khedarri D.D.S., Inc. · 1980
- This deviceK991888 MinijectSpartan Ultrasonics, Inc. · 1999
- 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 |
|---|---|---|---|---|---|
| −1 | K802483 | Ligmaject | Alan J. Khedarri D.D.S., Inc. | 1980 | — |
| 0 (this device) | K991888 | Miniject | Spartan Ultrasonics, Inc. | 1999 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
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), 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? (2)
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 |
|---|---|---|---|
| * | K823536 | IntraligSummary page 1…Predicate Device — Substantial Equivalence The Miniject Syringe is substantially equivalent in terms of safety and effectiveness to the marketed injection devices of (K823536) Intralig and (K802483) Ligmaject Device Description The Miniject Syringe is a cartridge syringe with a metal syringe barrel to… | 1982 |
| * | K802483 | LigmajectSummary page 1…stantial Equivalence The Miniject Syringe is substantially equivalent in terms of safety and effectiveness to the marketed injection devices of (K823536) Intralig and (K802483) Ligmaject Device Description The Miniject Syringe is a cartridge syringe with a metal syringe barrel to which the metal or pla… | 1980 |
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?
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?
of anaesthetic product, through a two-ended needle.
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/K991888 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991888: Miniject.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991888
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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