510(k) · Cleared

Cleared

Airgent, Model AG7000010

K082138510(k) TraditionalCleared Jan 23, 2009178-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

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

Cleared on Jan 23, 2009 as substantially equivalent to K960373 (Bioject, Inc., 1997) and 2 other predicates after a 178-day review. Its family tree reaches back 2 generations to 1994.

Decided: Jan 23, 2009
Review: 178 days
Class: Class II
Product code: KZE
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K920631 (1994). 5 ancestors in all. 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 deviceK082138 Airgent, Model AG7000010Perfaction, 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)	K082138	Airgent, Model AG7000010	Perfaction, Inc.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
2001	1	0
2002	1	0

FIG. 1 — Lineage of K082138, 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? (3)

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 …duct Code KZE, 21 C F R § 880 5430 Device Class Class II Classification Panel General Hospital Predicate Devices Biojector 2000 (Bioject Inc, K960373) Jet Syringe (Equidyne Systems, Inc, K003741) 2 Injex 30 (…	Bioject, Inc.	1997	—
*	K003741	Jet Syringe Model-100500 Summary page 1 …Class II Classification Panel General Hospital Predicate Devices Biojector 2000 (Bioject Inc, K960373) Jet Syringe (Equidyne Systems, Inc, K003741) 2 Injex 30 (Equidyne Systems, Inc, K022148) Intended Use/Indica…	Equidyne Systems, Inc.	2001	—
*	K022148	Injex 30 Needle Free Injection System Summary page 2 …ject Inc, K960373) Jet Syringe (Equidyne Systems, Inc, K003741) 2 Injex 30 (Equidyne Systems, Inc, K022148) Intended Use/Indications for Use The AirgentTM System is a needle-free injection system designed for the administr…	Equidyne Systems, Inc.	2002	—

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 15 years and passes through 2 companies; a new generation was cleared every 11.9 years on median.
None of the 5 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 Airgent System is a needle-free injection system designed for the administration of various medicines and vaccines to the body by means of a high velocity jet of fluid that penetrates the skin The Airgent includes a disposable delivery kit intended for multiple injections on a single patient The Airgent System is indicated for professional use only

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082138 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082138: Airgent, Model AG7000010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082138

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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