510(k) · Cleared
ClearedAstra Lightweight Stainless Steel Self Aspir/Syrin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astra Pharmaceutical Products, Inc. · EJI Syringe, Cartridge
Cleared on Jul 2, 1985 after a 63-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
- Jul 2, 1985
- Review
- 63 days
- Class
- Class II
- Product code
- EJI
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK851903 Astra Lightweight Stainless Steel Self Aspir/SyrinAstra Pharmaceutical Products, Inc. · 1985
- Descendant · cites it directly · 2 of its ownK083796 Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex…Miltex, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK962999 Safety Injection SystemIntegritech, Inc. · 1997
- Descendant · 2 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
- Descendant · 2 generations on · 0 of its ownK023722 Safetywand Disposable HandpieceSpintech, Inc. · 2003
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K083796Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex Self-Aspirating…Miltex, Inc. · 2009 · cites it directly2descendants
- K962999Safety Injection SystemIntegritech, Inc. · 1997 · cites it directly1descendant
- K171254LeEject 2 Dental Syringe and Needle SystemAdvanced Technology and Capital, Inc. · 2017 · 2 generations on0descendants
- K092943Aspirating Syringe, Non-Aspirating SyringeArnold Tuber Industries · 2009 · 2 generations on0descendants
- K023722Safetywand Disposable HandpieceSpintech, Inc. · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K851903 | Astra Lightweight Stainless Steel Self Aspir/Syrin | Astra Pharmaceutical Products, Inc. | 1985 | — |
| +1 | K083796 | Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex… | Miltex, Inc. | 2009 | — |
| +1 | K962999 | Safety Injection System | Integritech, Inc. | 1997 | — |
| +2 | 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 | — |
| +2 | K023722 | Safetywand Disposable Handpiece | Spintech, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2003 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
3 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, 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 | — |
https://510kreport.com/device/K851903 · printed Nov 5, 2026
Cite this page
510(k) Report. “K851903: Astra Lightweight Stainless Steel Self Aspir/Syrin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K851903
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026