510(k) · Cleared
ClearedInjex 30 Needle Free Injection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Equidyne Systems, Inc. · KZE Injector, Fluid, Non-Electrically Powered
Cleared on Jul 23, 2002 as substantially equivalent to K945873 (Equidyne Systems, Inc., 1995) after a 21-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Jul 23, 2002
- Review
- 21 days
- Class
- Class II
- Product code
- KZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945873 (1995). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K082138Airgent, Model AG7000010Perfaction, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945873 | Hypex (TM) Jet Injector | Equidyne Systems, Inc. | 1995 | — |
| 0 (this device) | K022148 | Injex 30 Needle Free Injection System | Equidyne Systems, Inc. | 2002 | — |
| +1 | K082138 | Airgent, Model AG7000010 | Perfaction, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 KZE? 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? (1)
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 |
|---|---|---|---|
| * | K945873 | Hypex (TM) Jet InjectorSummary page 1…Injector, Fluid, Non-Electrically Powered C: Predicate Device: Hypex Jet Injector Predicate 510(k) #: K945873 D. Device Description: Equidyne System lnjex 30 Injector System is a means of administering subcutan… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082138 | Airgent, Model AG7000010 | 2009 | 0 |
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 KZE devicesKZE Injector, Fluid, Non-Electrically Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KZE
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · KZE
220in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KZE
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KZE
1in 2025
MAUDE reports naming product code KZE, 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 | 54 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 4 | 220 | 0 | 8 |
| 2010 | 0 | — | 1 | 9 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 1 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 10 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The lnjex 30 Injector System is designed to deliver various
medicines and vaccines by means of a narrow, high velocity jet of
fluid which penetrates the surface of the skin and delivers the
medicine or vaccine to the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022148 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022148: Injex 30 Needle Free Injection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022148
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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