510(k) Report

510(k) · Cleared

Cleared

Avant Guardian 101

K024018510(k) TraditionalCleared Jan 17, 200344-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

Avant Medical Corporation · KZE Injector, Fluid, Non-Electrically Powered

Cleared on Jan 17, 2003 as substantially equivalent to K960373 (Bioject, Inc., 1997) and 4 other predicates after a 44-day review. Its family tree reaches back 3 generations to 1987.

Decided
Jan 17, 2003
Review
44 days
Class
Class II
Product code
KZE
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K864561 (1987). 9 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestor1997: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor1996: 1 other ancestor1988: 1 other ancestorK864561 · Derata Medi-Jector IV · Derata Corp. · 1987K960285 · Medi-Ject Corporation Medi-Jector Needle-Free Bio-Tropin Ddrug Delivery Systems 0.0058/0.0068(Inch Diameter Nozzleorific · Medi-Ject Corp. · 1996K962956 · Medi-Jector Choice Needle-Free Insulin Delivery System · Medi-Ject Corp. · 199619851990199520002005
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 2 other ancestors K962956 · Medi-Jector Choice Needle-Free Insulin Delivery System · Medi-Ject Corp. · 1996K960285 · Medi-Ject Corporation Medi-Jector Needle-Free Bio-Tropin Ddrug Delivery Systems 0.0058/0.0068(Inch Diameter Nozzleorific · Medi-Ject Corp. · 1996K864561 · Derata Medi-Jector IV · Derata Corp. · 19870
  1. Root · 3 generations backK864561 Derata Medi-Jector IVDerata Corp. · 1987
  2. 2 generations backK960285 Medi-Ject Corporation Medi-Jector Needle-Free Bio-Tropin Ddrug…Medi-Ject Corp. · 1996
  3. 1 generation backK962956 Medi-Jector Choice Needle-Free Insulin Delivery SystemMedi-Ject Corp. · 1996
  4. This deviceK024018 Avant Guardian 101Avant Medical Corporation · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K864561Derata Medi-Jector IVDerata Corp.1987—
−2K960285Medi-Ject Corporation Medi-Jector Needle-Free Bio-Tropin Ddrug Delivery…Medi-Ject Corp.1996—
−1K962956Medi-Jector Choice Needle-Free Insulin Delivery SystemMedi-Ject Corp.1996—
0 (this device)K024018Avant Guardian 101Avant Medical Corporation2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199410
199510
199610
199710
200010
FIG. 1 — Lineage of K024018, 1987–2003Source: 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 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? (5)

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
*K960373Biojector 2000 Model 1B02000
Summary page 2
…uivalence is Claimed: Avant GuardianTM101 is substantially equivalent to the following currently marketed jet injectors: 0 Bioject Biojector 2000 (K960373, K92063 1) Medi-Ject Vision (modification of the Medi-Ject Choice, K962956 and K994384) 0 Eq…
Bioject, Inc.1997—
*K920631Bioject Jet Injection System
Summary page 2
…is Claimed: Avant GuardianTM101 is substantially equivalent to the following currently marketed jet injectors: 0 Bioject Biojector 2000 (K960373, K92063 1) Medi-Ject Vision (modification of the Medi-Ject Choice, K962956 and K994384) 0 Equidyne Inj…
Bioject, Inc.1994—
*K962956Medi-Jector Choice Needle-Free Insulin Delivery System
Summary page 2
…rrently marketed jet injectors: 0 Bioject Biojector 2000 (K960373, K92063 1) Medi-Ject Vision (modification of the Medi-Ject Choice, K962956 and K994384) 0 Equidyne Injex 30 (K945873) Device Description: The Avant GuardianTM101 allows a medication or…
Medi-Ject Corp.1996—
*K994384Clicker
Summary page 2
…eted jet injectors: 0 Bioject Biojector 2000 (K960373, K92063 1) Medi-Ject Vision (modification of the Medi-Ject Choice, K962956 and K994384) 0 Equidyne Injex 30 (K945873) Device Description: The Avant GuardianTM101 allows a medication or vaccine to…
Bioject, Inc.2000—
*K945873Hypex (TM) Jet Injector
Summary page 2
…Biojector 2000 (K960373, K92063 1) Medi-Ject Vision (modification of the Medi-Ject Choice, K962956 and K994384) 0 Equidyne Injex 30 (K945873) Device Description: The Avant GuardianTM101 allows a medication or vaccine to be injected subcutaneously without…
Equidyne Systems, Inc.1995—

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 16 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
  • None of the 9 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

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—

What is it indicated for?

The Avant GuardianTM101 is designed to deliver various liquid medications and vaccines by penetrating the skin with a high-speed fluid jet and delivering the medication or vaccine to the underlying subcutaneous tissue.

Indications for use as stated in the FDA summary.

Also cleared against K960373

6 other devices cite the same predicate.

  • K121270Bioject Needle-Free Injection Management SystemBioject Medical Technologies, Inc. · 2012
  • K090959Lectrajet Needle-Free Injection System, Model: M3 RAD'Antonio Consultants International, Inc. (Dci) · 2009
  • K090003ZetajetBioject, Inc. · 20091 recall
  • K081532Pharmajet Needle-Free Injection SystemPharmajet, Inc. · 2009
  • K082138Airgent, Model AG7000010Perfaction, Inc. · 2009
  • K032976Biovalve Miniject Needle-Free Injection System, Model FG-01-001Biovalve Technologies, Inc. · 2004

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/K024018 · printed Nov 6, 2026

Cite this page

510(k) Report. “K024018: Avant Guardian 101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024018

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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