510(k) · Cleared
ClearedConfidose IM Auto-Injector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharma-Pen, Inc. · KZH Introducer, Syringe Needle
Cleared on Jun 6, 2006 as substantially equivalent to K033696 (Union Medico Aps, 2005) and 2 other predicates after a 112-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Jun 6, 2006
- Review
- 112 days
- Class
- Class II
- Product code
- KZH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K860284 (1986). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK860284 Diamatic, Automatic Insulin InjectorUlster Scientific, Inc. · 1986
- 2 generations backK974678 B-D Auto-InjectorBd Becton Dickinson Vacutainer Systems Preanalytic · 1998
- 1 generation backK032425 Invisiject Resusable Auto-InjectorBiogen · 2003
- This deviceK060389 Confidose IM Auto-InjectorPharma-Pen, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K860284 | Diamatic, Automatic Insulin Injector | Ulster Scientific, Inc. | 1986 | — |
| −2 | K974678 | B-D Auto-Injector | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | — |
| −1 | K032425 | Invisiject Resusable Auto-Injector | Biogen | 2003 | — |
| 0 (this device) | K060389 | Confidose IM Auto-Injector | Pharma-Pen, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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? (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 | Decided |
|---|---|---|---|
| * | K033696 | Personal InjectorSummary page 1…Product Code: KZH Device Class: Class II Predicate Devices: * Union Medico Aps.; Personal Injector (K033696), * Biogen; InvisijectTM Reusable Auto Injector (K032425),… | 2005 |
| * | K032425 | Invisiject Resusable Auto-InjectorSummary page 1…es: * Union Medico Aps.; Personal Injector (K033696), * Biogen; InvisijectTM Reusable Auto Injector (K032425), * Pharma-Pen Inc.; ConfiDose Auto-Injector (K042557). Intended Use: The Conf… | 2003 |
| * | K042557 | Innoject Auto-InjectorSummary page 1…* Biogen; InvisijectTM Reusable Auto Injector (K032425), * Pharma-Pen Inc.; ConfiDose Auto-Injector (K042557). Intended Use: The ConfiDoseTM IM auto-injector is a semi-automatic injection system intended… | 2004 |
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 20 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 1 other device also cites its predicate K033696.
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 ConflDoseTM IM auto-injector is a semi-automatic injection system intended to be used for the manual transfer, containment and intramuscular injection of liquid drugs and biologics under the direction of a physician. The ConflDoseTM IM auto-injector system includes an automatic needle retraction mechanism that is intended to aid in the prevention of accidental needle sticks. The ConfiDoseTM IM auto-injector system is intended to mask needle insertion, injection and needle withdrawal from patient view.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060389 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060389: Confidose IM Auto-Injector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060389
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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