510(k) · Cleared

Recalled · 2010

Zetajet

K090003510(k) AbbreviatedCleared Apr 2, 200990-day reviewClass II21 CFR 880.5430Recalls 1

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

Bioject, Inc. · KZE Injector, Fluid, Non-Electrically Powered

Cleared on Apr 2, 2009 as substantially equivalent to K960373 (Bioject, Inc., 1997) after a 90-day review. Its family tree reaches back 2 generations to 1994. It has been recalled once.

Decided: Apr 2, 2009
Review: 90 days
Class: Class II
Product code: KZE
Recalls: 1
Predicates: 1

Its longest line of descent runs back 2 generations to K920631 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK920631 Bioject Jet Injection SystemBioject, Inc. · 1994
1 generation backK960373 Biojector 2000 Model 1B02000Bioject, Inc. · 1997
This deviceK090003 ZetajetBioject, Inc. · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K920631	Bioject Jet Injection System	Bioject, Inc.	1994	—
−1	K960373	Biojector 2000 Model 1B02000	Bioject, Inc.	1997	—
0 (this device)	K090003	Zetajet	Bioject, Inc.	2009	—

FIG. 1 — Lineage of K090003, 1994–2009Source: 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

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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	Applicant	Decided	Recalls
*	K960373	Biojector 2000 Model 1B02000 Summary page 1 …ctor, Fluid, Non-Electrically Powered (Class II, KZE, 880.5430) Predicate Device: BiojectorO 2000 (B2000) Jet Injection System (K960373) Device Description: The Zetajet Needle-free Injection Therapy System is a compact, spring-powered, needle- free delivery system.…	Bioject, Inc.	1997	—

Also cleared against K960373: 6 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)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 1, 2010	Not classified	Z-1541-2012	Software design	Labeling clarification and software updates to include fixes for end of run summaries, increasing boot reliability, corrections to the double red blood cell count collection TBV limit, and to be in compliance with the most current FDA…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 15 years and passes through 1 company; a new generation was cleared every 12.1 years on median.
None of the 2 ancestors has a recall.
6 other devices also cite its predicate K960373.

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. 2009, this device’s year, is highlighted.

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 Zetajet is indicated for delivery of subcutaneous or intramuscular injections of vaccines and other injectable drugs into standard injection sites. The Zetajet may be used by physicians, nurses, veterinarians, podiatrists and other practitioners who routinely administer injections. The Zetajet may also be used by patients authorized by their physicians to self inject, or have other individuals administer injections of prescribed medication.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090003 · printed Nov 4, 2026

Cite this page

510(k) Report. “K090003: Zetajet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090003

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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