510(k) · Cleared
ClearedIntralig
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Miltex Instrument Co. · EJI Syringe, Cartridge
Cleared on Dec 28, 1982 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Dec 28, 1982
- Review
- 28 days
- Class
- Class II
- Product code
- EJI
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK823536 IntraligMiltex Instrument Co. · 1982
- Descendant · cites it directly · 4 of its ownK991888 MinijectSpartan Ultrasonics, Inc. · 1999
- Descendant · 2 generations on · 3 of its ownK040671 Eroject, Miniject, Self Aspirating Syringes, Aspirating Syringes…Anthogyr · 2004
- Descendant · 3 generations on · 2 of its ownK083796 Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex…Miltex, Inc. · 2009
- Descendant · 4 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 ownK142414 Miltex N-Tralig Intraligamentary SyringeIntegra LifeSciences Corporation · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K991888MinijectSpartan Ultrasonics, Inc. · 1999 · cites it directly4descendants
- K040671Eroject, Miniject, Self Aspirating Syringes, Aspirating Syringes, Non Aspirating SyringesAnthogyr · 2004 · 2 generations on3descendants
- K083796Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex Self-Aspirating…Miltex, Inc. · 2009 · 3 generations on2descendants
- K171254LeEject 2 Dental Syringe and Needle SystemAdvanced Technology and Capital, Inc. · 2017 · 4 generations on0descendants
- K142414Miltex N-Tralig Intraligamentary SyringeIntegra LifeSciences Corporation · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K823536 | Intralig | Miltex Instrument Co. | 1982 | — |
| +1 | K991888 | Miniject | Spartan Ultrasonics, Inc. | 1999 | — |
| +2 | K040671 | Eroject, Miniject, Self Aspirating Syringes, Aspirating Syringes, Non… | Anthogyr | 2004 | — |
| +3 | K083796 | Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex… | Miltex, Inc. | 2009 | — |
| +4 | K171254 | LeEject 2 Dental Syringe and Needle System | Advanced Technology and Capital, Inc. | 2017 | — |
| +1 | K142414 | Miltex N-Tralig Intraligamentary Syringe | Integra LifeSciences Corporation | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 2 | 0 |
| 2014 | 1 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
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?
- Of its descendants, K991888 (Spartan Ultrasonics, Inc., 1999) has gone furthest, with 4 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/K823536 · printed Nov 6, 2026
Cite this page
510(k) Report. “K823536: Intralig.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K823536
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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