510(k) Report

510(k) · Cleared

Cleared

Injex 50 System

K003864510(k) TraditionalCleared Mar 6, 200183-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

Equidyne Systems, Inc. · KZE Injector, Fluid, Non-Electrically Powered

Cleared on Mar 6, 2001 after an 83-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Mar 6, 2001
Review
83 days
Class
Class II
Product code
KZE
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared200020052010201520202025
  1. This deviceK003864 Injex 50 SystemEquidyne Systems, Inc. · 2001
  2. Descendant · cites it directly · 0 of its ownK020786 Injex Needle-Free Injection System; Rojex Needle-Free Injection SystemRosch AG Medizintechnic · 2002

Most influential descendants

Showing 1 of 1 · See all
  • K020786Injex Needle-Free Injection System; Rojex Needle-Free Injection SystemRosch AG Medizintechnic · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003864Injex 50 SystemEquidyne Systems, Inc.2001—
+1K020786Injex Needle-Free Injection System; Rojex Needle-Free Injection SystemRosch AG Medizintechnic2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K003864, 2001–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K020786Injex Needle-Free Injection System; Rojex Needle-Free Injection SystemRosch AG Medizintechnic20020

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?

  • Of its descendants, K020786 (Rosch AG Medizintechnic, 2002) has gone furthest, with 0 descendants of its own.

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

2009: 42011: 22012: 1
2007high 4 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KZE

220in 2009

2009: 220 days median
2007high 220 (2009)2026

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

Recalls per year · KZE

1in 2010

2010: 1
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

2007: 542008: 52009: 82010: 92011: 72012: 62013: 42014: 102019: 12022: 12024: 12025: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—054
20080—05
2009422008
20100—19
20112—07
20121—06
20130—04
20140—010
20150—00
20160—00
20170—00
20180—00
20190—01
20200—00
20210—00
20220—01
20230—00
20240—01
20250—01
20260—0—

More from Equidyne Systems, Inc.

5 FDA decisions under this applicant name. See the company

  • K022502Injex 30 Needle Free Injection System, Model 100000Equidyne Systems, Inc. · 2002
  • K022148Injex 30 Needle Free Injection SystemEquidyne Systems, Inc. · 2002
  • K003741Jet Syringe Model-100500Equidyne Systems, Inc. · 2001
  • K945873Hypex (TM) Jet InjectorEquidyne Systems, Inc. · 1995

Recent decisions in KZE

The KZE category page

  • K121270Bioject Needle-Free Injection Management SystemBioject Medical Technologies, Inc. · 2012
  • K111517Pharmajet Stratis 0.5 ML Needle-Free Injection System Model 501-01, Stratis Injector Catalog 501-10, Stratis…Pharmajet, Inc. · 2011
  • K110456Pharmajet 0.1 ML Intradermal Needle-Free Injection SystemPharmajet, Inc. · 2011
  • K090959Lectrajet Needle-Free Injection System, Model: M3 RAD'Antonio Consultants International, Inc. (Dci) · 2009
  • K090003ZetajetBioject, Inc. · 20091 recall

https://510kreport.com/device/K003864 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003864: Injex 50 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003864

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026