510(k) · Cleared
ClearedLectrajet Needle-Free Injection System, Model: M3 RA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
D'Antonio Consultants International, Inc. (Dci) · KZE Injector, Fluid, Non-Electrically Powered
Cleared on Dec 24, 2009 as substantially equivalent to K960373 (Bioject, Inc., 1997) and 1 other predicate after a 262-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Dec 24, 2009
- Review
- 262 days
- Class
- Class II
- Product code
- KZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K864561 (1987). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK864561 Derata Medi-Jector IVDerata Corp. · 1987
- 2 generations backK960285 Medi-Ject Corporation Medi-Jector Needle-Free Bio-Tropin Ddrug…Medi-Ject Corp. · 1996
- 1 generation backK962956 Medi-Jector Choice Needle-Free Insulin Delivery SystemMedi-Ject Corp. · 1996
- This deviceK090959 Lectrajet Needle-Free Injection System, Model: M3 RAD'Antonio Consultants International, Inc. (Dci) · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K864561 | Derata Medi-Jector IV | Derata Corp. | 1987 | — |
| −2 | K960285 | Medi-Ject Corporation Medi-Jector Needle-Free Bio-Tropin Ddrug Delivery… | Medi-Ject Corp. | 1996 | — |
| −1 | K962956 | Medi-Jector Choice Needle-Free Insulin Delivery System | Medi-Ject Corp. | 1996 | — |
| 0 (this device) | K090959 | Lectrajet Needle-Free Injection System, Model: M3 RA | D'Antonio Consultants International, Inc. (Dci) | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 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? (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 |
|---|---|---|---|
| * | K960373 | Biojector 2000 Model 1B02000Summary page 1…Jet Injector, Non Electrically Powered Fluid Injector Predicate Device: Biojector 2000®, ~K960373 Medi-Jector Vision® K962956 D… | 1997 |
| * | K962956 | Medi-Jector Choice Needle-Free Insulin Delivery SystemSummary page 1…2000®, ~K960373 Medi-Jector Vision® K962956 Dvce Dsrpion:.h components ofteLcraet Nel-ree Injection… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- None of the 6 ancestors has a recall.
- 6 other devices also cite its predicate K960373.
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. 2009, this device’s year, is highlighted.
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 LectraJet Needle-Free Injection System is intended to deliver subcutaneous (SO) or intramuscular (IM) injections of vaccines and other injectable medications.
The LectraJet Needle-Free Injection System may be used by physicians, nurses, veterinarians, podiatrists and other practitioners who routinely administer injections.
The LectraJet Needle-Free Injection System may also be used by patients to self inject or to have other individuals administer injections of prescribed medications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090959 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090959: Lectrajet Needle-Free Injection System, Model: M3 RA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090959
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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