510(k) · Cleared

Cleared

Injex Needle-Free Injection System; Rojex Needle-Free Injection System

K020786510(k) TraditionalCleared Sep 25, 2002198-day reviewClass II21 CFR 880.5430

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Rosch AG Medizintechnic · KZE Injector, Fluid, Non-Electrically Powered

Cleared on Sep 25, 2002 as substantially equivalent to K945873 (Equidyne Systems, Inc., 1995) and 3 other predicates after a 198-day review. Its family tree reaches back 3 generations to 1987.

Decided: Sep 25, 2002
Review: 198 days
Class: Class II
Product code: KZE
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K864561 (1987). 8 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

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 deviceK020786 Injex Needle-Free Injection System; Rojex Needle-Free Injection SystemRosch AG Medizintechnic · 2002

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)	K020786	Injex Needle-Free Injection System; Rojex Needle-Free Injection System	Rosch AG Medizintechnic	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0
1994	1	0
1995	1	0
2001	2	0

FIG. 1 — Lineage of K020786, 1987–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K945873	Hypex (TM) Jet Injector Summary page 1 …et Injector, Medi-Jector Choice, INJEX 50 System, Jet Syringe Predicate 510(k) #: K945873; K962956, K003864, KO03741 Device Description: The lNJEXTMand R O J E P Systems Exfra are medical devices to…	Equidyne Systems, Inc.	1995	—
*	K962956	Medi-Jector Choice Needle-Free Insulin Delivery System Summary page 1 …or, Medi-Jector Choice, INJEX 50 System, Jet Syringe Predicate 510(k) #: K945873; K962956, K003864, KO03741 Device Description: The lNJEXTMand R O J E P Systems Exfra are medical devices to apply liq…	Medi-Ject Corp.	1996	—
*	K003864	Injex 50 System Summary page 1 …Jector Choice, INJEX 50 System, Jet Syringe Predicate 510(k) #: K945873; K962956, K003864, KO03741 Device Description: The lNJEXTMand R O J E P Systems Exfra are medical devices to apply liquid medic…	Equidyne Systems, Inc.	2001	—
*	K003741	Jet Syringe Model-100500	Equidyne Systems, Inc.	2001	—

Also cleared against K945873: 2 other devices →

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 15 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
None of the 8 ancestors has a recall.
2 other devices also cite its predicate K945873.

How does its category compare?

All KZE devices

KZE Injector, Fluid, Non-Electrically Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KZE

1in 2012

2007high 4 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KZE

220in 2009

2007high 220 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KZE

1in 2010

2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KZE

1in 2025

2007high 54 (2007) · low 0 (2015)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 INJEX TM- and ROJEX TM needle-free Injection System Extra is exclusively designed to deliver medicines that can be administrated subcutaneously by jet injection propelling a jet of liquid medicine through the skin into subcutaneous tissue under high pressure.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K020786 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020786: Injex Needle-Free Injection System; Rojex 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/K020786

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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