510(k) · Cleared
ClearedMiltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex Self-Aspirating Syringe, Miltex Lightweight
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Miltex, Inc. · EJI Syringe, Cartridge
Cleared on Mar 9, 2009 as substantially equivalent to K040671 (Anthogyr, 2004) and 1 other predicate after a 77-day review. Its family tree reaches back 3 generations to 1980. 2 later devices descend from it.
- Decided
- Mar 9, 2009
- Review
- 77 days
- Class
- Class II
- Product code
- EJI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K802483 (1980). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK802483 LigmajectAlan J. Khedarri D.D.S., Inc. · 1980
- 2 generations backK991888 MinijectSpartan Ultrasonics, Inc. · 1999
- 1 generation backK040671 Eroject, Miniject, Self Aspirating Syringes, Aspirating Syringes…Anthogyr · 2004
- This deviceK083796 Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex…Miltex, Inc. · 2009
- Descendant · cites it directly · 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K802483 | Ligmaject | Alan J. Khedarri D.D.S., Inc. | 1980 | — |
| −2 | K991888 | Miniject | Spartan Ultrasonics, Inc. | 1999 | — |
| −1 | K040671 | Eroject, Miniject, Self Aspirating Syringes, Aspirating Syringes, Non… | Anthogyr | 2004 | — |
| 0 (this device) | K083796 | Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex… | Miltex, Inc. | 2009 | — |
| +1 | 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 |
| 1985 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K040671 | Eroject, Miniject, Self Aspirating Syringes, Aspirating Syringes, Non Aspirating SyringesSummary page 1…eamendment Cartridge Syringes Union Broach Co. (now Miltex, inc.) Preamendment Anesthetic Syringes Henke-Sass, Wolf GmbH K04067 1 Anthogyr Cartridge Syringes Anthogyr K85 1903 Astra Self-Aspirating Syringe Astra Pharmaceu… | 2004 |
| * | K851903 | Astra Lightweight Stainless Steel Self Aspir/SyrinSummary page 1…h Co. (now Miltex, inc.) Preamendment Anesthetic Syringes Henke-Sass, Wolf GmbH K04067 1 Anthogyr Cartridge Syringes Anthogyr K85 1903 Astra Self-Aspirating Syringe Astra Pharmaceutical Products, Inc. Substantial Equivalence: Miltexo Dental Aspi… | 1985 |
| * | — | Cartridge Syringes Named without a submission number | |
| * | — | Anesthetic Syringes Named without a submission number |
What descends from it? (2)
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 29 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K171254 (Advanced Technology and Capital, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K040671.
How does its category compare?
All EJI devicesEJI Syringe, Cartridge: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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?
Miltex® Dental Aspirating Syringes are indicated to be used in conjunction with anesthetic needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083796 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083796: Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex Self-Aspirating Syringe, Miltex Lightweight.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083796
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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