510(k) · Cleared

Cleared

Biovalve Miniject Needle-Free Injection System, Model FG-01-001

K032976510(k) TraditionalCleared Apr 16, 2004205-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

Biovalve Technologies, Inc. · KZE Injector, Fluid, Non-Electrically Powered

Cleared on Apr 16, 2004 as substantially equivalent to K960373 (Bioject, Inc., 1997) and 1 other predicate after a 205-day review. Its family tree reaches back 2 generations to 1994.

Decided: Apr 16, 2004
Review: 205 days
Class: Class II
Product code: KZE
Recalls: None
Predicates: 2

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 deviceK032976 Biovalve Miniject Needle-Free Injection System, Model FG-01-001Biovalve Technologies, Inc. · 2004

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)	K032976	Biovalve Miniject Needle-Free Injection System, Model FG-01-001	Biovalve Technologies, Inc.	2004	—

FIG. 1 — Lineage of K032976, 1994–2004Source: 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? (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	Applicant	Decided	Recalls
*	K960373	Biojector 2000 Model 1B02000 Summary page 1 …product code KZE Classification: Class fl Predicatc Devicc: Bioject, Riojector 2000, K960373 and Kg20631 Device Description: The Mini-Ject is a sterile, single use medical device. The Mini-Ject delivers 0.5ml subcutaneo…	Bioject, Inc.	1997	—
*	K920631	Bioject Jet Injection System Summary page 1 …ed device is substantially equivalent to legally marketed devices. The proposed Mini-Ject device is substantially equivalent to the Bioject, Biojector 2000 (Kg60373 and K920631). Both devices have the same intended use to deliver medicinal to thc subcutaneous tissue and both arc self-filled. A comparis…	Bioject, Inc.	1994	—

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)

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 10 years and passes through 2 companies; a new generation was cleared every 7.1 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.

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 Mini-Ject device is a needle-free injection system designed to deliver fluid subcutaneously. This non-electrically powered device is intended to deliver an injection of fluid by means of a high velocity jet of fluid that penetrates the skin and delivers the fluid to the subcutaneous area of the body. The Mini-Ject device is intended for home and professional use. It may be used by physicians, nurses and other practitioners who routinely administer injections and by patients authorized by their physician to self inject medication.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032976 · printed Nov 4, 2026

Cite this page

510(k) Report. “K032976: Biovalve Miniject Needle-Free Injection System, Model FG-01-001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032976

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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