510(k) · Cleared

Cleared

Medi-Ject Corporation Medi-Jector Needle-Free Bio-Tropin Ddrug Delivery Systems 0.0058/0.0068(Inch Diameter Nozzleorific

K960285510(k) TraditionalCleared Apr 17, 199689-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

Medi-Ject Corp. · KZE Injector, Fluid, Non-Electrically Powered

Cleared on Apr 17, 1996 as substantially equivalent to K864561 (Derata Corp., 1987) and 2 other predicates after an 89-day review. Its family tree reaches back 1 generation to 1987. 9 later devices descend from it.

Decided: Apr 17, 1996
Review: 89 days
Class: Class II
Product code: KZE
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K864561 (1987). 3 ancestors in all. 9 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK864561 Derata Medi-Jector IVDerata Corp. · 1987
This deviceK960285 Medi-Ject Corporation Medi-Jector Needle-Free Bio-Tropin Ddrug…Medi-Ject Corp. · 1996
Descendant · cites it directly · 5 of its ownK962956 Medi-Jector Choice Needle-Free Insulin Delivery SystemMedi-Ject Corp. · 1996
Descendant · cites it directly · 3 of its ownK994384 ClickerBioject, Inc. · 2000
Descendant · 2 generations on · 1 of its ownK050734 Cool.ClickBioject, Inc. · 2005
Descendant · 2 generations on · 1 of its ownK991294 Modification to Medi-Ject Corporation Medi-Jector Choice Needle-Free…Medi-Ject Corp. · 1999
Descendant · 2 generations on · 0 of its ownK090959 Lectrajet Needle-Free Injection System, Model: M3 RAD'Antonio Consultants International, Inc. (Dci) · 2009

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

1996high 2 (2002) · low 0 (1997)2026

Most influential descendants

Showing 5 of 9 · See all

K962956Medi-Jector Choice Needle-Free Insulin Delivery SystemMedi-Ject Corp. · 1996 · cites it directly5descendants
K994384ClickerBioject, Inc. · 2000 · cites it directly3descendants
K050734Cool.ClickBioject, Inc. · 2005 · 2 generations on1descendant
K991294Modification to Medi-Ject Corporation Medi-Jector Choice Needle-Free Insulin Delivery…Medi-Ject Corp. · 1999 · 2 generations on1descendant
K090959Lectrajet Needle-Free Injection System, Model: M3 RAD'Antonio Consultants International, Inc. (Dci) · 2009 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K864561	Derata Medi-Jector IV	Derata Corp.	1987	—
0 (this device)	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	—
+1	K994384	Clicker	Bioject, Inc.	2000	—
+2	K050734	Cool.Click	Bioject, Inc.	2005	—
+2	K991294	Modification to Medi-Ject Corporation Medi-Jector Choice Needle-Free Insulin…	Medi-Ject Corp.	1999	—
+2	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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1999	1	0
2000	1	0
2002	2	0
2003	1	0
2005	1	0
2006	1	0
2009	1	0

FIG. 1 — Lineage of K960285, 1987–2009Source: 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

Get a 510(k) Report

What was it cleared against? (3)

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
*	K864561	Derata Medi-Jector IV Summary page 1 …an Growth Hormone Injection System to the Medi-Ject Corporation Medi-Jector IV(EZ) and Medi-Jector V (TT) Needle- Free Insulin Injection Systems, the subjects of 510(k)s K864561 and K883847, respectively, and to the Bioject Inc., Biojector 2000 Needle-Free Injection Management System, described in 510(k) K…	Derata Corp.	1987	—
*	K883847	Derata Medi-Jector V Summary page 1 …rmone Injection System to the Medi-Ject Corporation Medi-Jector IV(EZ) and Medi-Jector V (TT) Needle- Free Insulin Injection Systems, the subjects of 510(k)s K864561 and K883847, respectively, and to the Bioject Inc., Biojector 2000 Needle-Free Injection Management System, described in 510(k) K920631.1 Th…	Derata Corp.	1988	—
*	K920631	Bioject Jet Injection System Summary page 1 …Systems, the subjects of 510(k)s K864561 and K883847, respectively, and to the Bioject Inc., Biojector 2000 Needle-Free Injection Management System, described in 510(k) K920631.1 The Medi-Jector Needle-Free Human Growth Hormone Injection System is a needle-free, spring- powered human growth hormone (hGH)…	Bioject, Inc.	1994	—

Also cleared against K864561: 1 other device →

What descends from it? (9)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K962956	Medi-Jector Choice Needle-Free Insulin Delivery System	Medi-Ject Corp.	1996	5
K994384	Clicker	Bioject, Inc.	2000	3

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?

None of the 3 ancestors has a recall.
Of its descendants, K962956 (Medi-Ject Corp., 1996) has gone furthest, with 5 descendants of its own.
1 other device also cites its predicate K864561.

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 device is intended only for the long-term treatment of children who have growth failure due to an inadequate secretion of normal endogenous growth hormone. It is intended for the subcutaneous administration of the reconstituted drug by high-pressure injection either by health care practitioners or directly by patients.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K960285 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960285: Medi-Ject Corporation Medi-Jector Needle-Free Bio-Tropin Ddrug Delivery Systems 0.0058/0.0068(Inch Diameter Nozzleorific.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960285

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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