510(k) · Cleared
ClearedInvisiject Resusable Auto-Injector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biogen · KZH Introducer, Syringe Needle
Cleared on Nov 5, 2003 as substantially equivalent to K974678 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1998) and 1 other predicate after a 91-day review. Its family tree reaches back 2 generations to 1986. 2 later devices descend from it.
- Decided
- Nov 5, 2003
- Review
- 91 days
- Class
- Class II
- Product code
- KZH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K860284 (1986). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK860284 Diamatic, Automatic Insulin InjectorUlster Scientific, Inc. · 1986
- 1 generation backK974678 B-D Auto-InjectorBd Becton Dickinson Vacutainer Systems Preanalytic · 1998
- This deviceK032425 Invisiject Resusable Auto-InjectorBiogen · 2003
- Descendant · cites it directly · 0 of its ownK060389 Confidose IM Auto-InjectorPharma-Pen, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK042314 Syringe Grip for the Avonex Pre-Filled SyringeBiogen · 2004
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K860284 | Diamatic, Automatic Insulin Injector | Ulster Scientific, Inc. | 1986 | — |
| −1 | K974678 | B-D Auto-Injector | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | — |
| 0 (this device) | K032425 | Invisiject Resusable Auto-Injector | Biogen | 2003 | — |
| +1 | K060389 | Confidose IM Auto-Injector | Pharma-Pen, Inc. | 2006 | — |
| +1 | K042314 | Syringe Grip for the Avonex Pre-Filled Syringe | Biogen | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
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 K243232 GripMatescore 9.3 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (4)
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 | Decided |
|---|---|---|---|
| * | K974678 | B-D Auto-InjectorSummary page 1…e 8.5 Substantial Equivalence: The InvisijectmReusable Auto-Injector is substantially equivalent to the B-D Auto- Injector (K974678), the Owen Mumford Autoject 2 (KO13362), the standard Piston Syringe (Numerous Devices) and Meridian's EpiPenB (NDA… | 1998 |
| * | K013362 | Autoject 2 | 2001 |
| * | — | standard Piston Syringe Named without a submission number | |
| * | — | Meridian's EpiPen Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 3 companies; a new generation was cleared every 12.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K060389 (Pharma-Pen, Inc., 2006) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K974678.
How does its category compare?
All KZH devicesKZH Introducer, Syringe Needle: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KZH
1in 2024
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KZH
16in 2025
MAUDE reports naming product code KZH, 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 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 1 | 20 |
| 2012 | 2 | — | 0 | 20 |
| 2013 | 1 | — | 0 | 53 |
| 2014 | 1 | — | 0 | 138 |
| 2015 | 0 | — | 0 | 99 |
| 2016 | 1 | — | 0 | 68 |
| 2017 | 1 | — | 0 | 88 |
| 2018 | 0 | — | 0 | 88 |
| 2019 | 0 | — | 2 | 95 |
| 2020 | 0 | — | 0 | 158 |
| 2021 | 0 | — | 0 | 87 |
| 2022 | 1 | — | 0 | 58 |
| 2023 | 0 | — | 0 | 35 |
| 2024 | 1 | — | 0 | 27 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Invisijectr" Reusable Auto-Injector is a reusable device indicated for use by the patient to assist with the self-administered injection of a fixed dose of AVONE? from a pre-filled syringe through a single lumen hypodermic needle. The auto-injectors are intended to be used in any setting including the home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032425 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032425: Invisiject Resusable Auto-Injector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032425
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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