510(k) · Cleared

Cleared

Easy-Jet Device

K972383510(k) TraditionalCleared Nov 23, 1999880-day reviewClass II21 CFR 874.3850

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

A.Stein - Regulatory Affairs Consulting · KLZ Tube, Shunt, Endolymphatic With Valve

Cleared on Nov 23, 1999 after an 880-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided: Nov 23, 1999
Review: 880 days
Class: Class II
Product code: KLZ
Recalls: None
Predicates: 0

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

This deviceK972383 Easy-Jet DeviceA.Stein - Regulatory Affairs Consulting · 1999
Descendant · cites it directly · 0 of its ownK051667 EZ-JectIndolor, Ltd. · 2005

Most influential descendants

Showing 1 of 1 · See all

K051667EZ-JectIndolor, Ltd. · 2005 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K972383	Easy-Jet Device	A.Stein - Regulatory Affairs Consulting	1999	—
+1	K051667	EZ-Ject	Indolor, Ltd.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0

FIG. 1 — Lineage of K972383, 1999–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KLZ? 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K051667	EZ-Ject	Indolor, Ltd.	2005	0

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, K051667 (Indolor, Ltd., 2005) has gone furthest, with 0 descendants of its own.

How does its category compare?

All KLZ devices

KLZ Tube, Shunt, Endolymphatic With Valve: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KLZ

FDA has decided no KLZ device since 2007.

Median 510(k) review, days · KLZ

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

Recalls per year · KLZ

No recall names KLZ since 2007.

Adverse event reports per year · KLZ

3in 2025

2007high 3 (2025) · low 0 (2007)2025

MAUDE reports naming product code KLZ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	3
2026	—	—

What is it indicated for?

The Easy-Ject device is an automatic injection device with a cooling mechanism, for insulin injection and ncedle withdrawal.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K972383 · printed Nov 5, 2026

Cite this page

510(k) Report. “K972383: Easy-Jet Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972383

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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