510(k) Report

510(k) · Cleared

Cleared

EZ-Ject

K051667510(k) TraditionalCleared Sep 27, 200597-day reviewClass II21 CFR 880.6920

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

Indolor, Ltd. · KZH Introducer, Syringe Needle

Cleared on Sep 27, 2005 as substantially equivalent to K972383 (A.Stein - Regulatory Affairs Consulting, 1999) after a 97-day review. Its family tree reaches back 1 generation to 1999.

Decided
Sep 27, 2005
Review
97 days
Class
Class II
Product code
KZH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K972383 (1999). No later device cites it as a predicate yet.

K972383 · Easy-Jet Device · A.Stein - Regulatory Affairs Consulting · 1999199619982000200220042006
K972383 · Easy-Jet Device · A.Stein - Regulatory Affairs Consulting · 19990
  1. Root · 1 generation backK972383 Easy-Jet DeviceA.Stein - Regulatory Affairs Consulting · 1999
  2. This deviceK051667 EZ-JectIndolor, Ltd. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K972383Easy-Jet DeviceA.Stein - Regulatory Affairs Consulting1999—
0 (this device)K051667EZ-JectIndolor, Ltd.2005—
FIG. 1 — Lineage of K051667, 1999–2005Source: 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), 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 KZH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KZH device

  1. #1 K243232 GripMatescore 9.3 · 4 generations · no Class I recall
  2. #2 Held for the reportin 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.

TypeNumberDeviceApplicantDecidedRecalls
*K972383Easy-Jet Device
Summary page 1
…Syringe Needle Introducer, Class 2, Product Code 80KZH, Name: 21 CFR 880.6920 3. Predicate Devices: Easy-Ject Automatic Injector Device K972383 4. Description: The Modified Easy-Ject Automatic Injector is a hand held device that…
A.Stein - Regulatory Affairs Consulting1999—

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?

  • Its one ancestor has no recall.

How does its category compare?

All KZH devices

KZH Introducer, Syringe Needle: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KZH

1in 2024

2007: 12008: 22012: 22013: 12014: 12016: 12017: 12022: 12024: 1
2007high 2 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KZH

Too few KZH 510(k)s in any year since 2007 to give a median.

Recalls per year · KZH

2in 2019

2011: 12019: 2
2007high 2 (2019) · low 0 (2007)2026

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

Adverse event reports per year · KZH

16in 2025

2007: 22010: 32011: 202012: 202013: 532014: 1382015: 992016: 682017: 882018: 882019: 952020: 1582021: 872022: 582023: 352024: 272025: 16
2007high 158 (2020) · low 0 (2008)2025

MAUDE reports naming product code KZH, 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
20071—02
20082—00
20090—00
20100—03
20110—120
20122—020
20131—053
20141—0138
20150—099
20161—068
20171—088
20180—088
20190—295
20200—0158
20210—087
20221—058
20230—035
20241—027
20250—016
20260—0—

What is it indicated for?

The Modified Easy-Ject Automatic Injector Device (also known as EZ-Ject) is an automatic injection device with a cooling mechanism for injection and needle withdrawal.

Indications for use as stated in the FDA summary.

Recent decisions in KZH

The KZH category page

  • K243232GripMateSynthon Hispania S.L. · 2024
  • K213429AccuSert Needle InserterEmed Technologies Corporation · 2022
  • K163400Orbit InserterYpsomed AG · 2017
  • K160860MiniMed Quick-serterMedtronic Minimed · 2016
  • K141384Whisperject AutoinjectorScandinavian Health Limited · 2014

https://510kreport.com/device/K051667 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051667: EZ-Ject.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051667

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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