510(k) · Cleared
ClearedDiamatic, Automatic Insulin Injector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ulster Scientific, Inc. · KZH Introducer, Syringe Needle
Cleared on Apr 7, 1986 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Apr 7, 1986
- Review
- 69 days
- Class
- Class II
- Product code
- KZH
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK860284 Diamatic, Automatic Insulin InjectorUlster Scientific, Inc. · 1986
- Descendant · cites it directly · 4 of its ownK974678 B-D Auto-InjectorBd Becton Dickinson Vacutainer Systems Preanalytic · 1998
- Descendant · 2 generations on · 2 of its ownK032425 Invisiject Resusable Auto-InjectorBiogen · 2003
- Descendant · 2 generations on · 1 of its ownK042557 Innoject Auto-InjectorInnoject, Inc. · 2004
- Descendant · 3 generations on · 0 of its ownK060389 Confidose IM Auto-InjectorPharma-Pen, Inc. · 2006
- Descendant · 3 generations on · 0 of its ownK042314 Syringe Grip for the Avonex Pre-Filled SyringeBiogen · 2004
Most influential descendants
Showing 5 of 5 · See all- K974678B-D Auto-InjectorBd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · cites it directly4descendants
- K032425Invisiject Resusable Auto-InjectorBiogen · 2003 · 2 generations on2descendants
- K042557Innoject Auto-InjectorInnoject, Inc. · 2004 · 2 generations on1descendant
- K060389Confidose IM Auto-InjectorPharma-Pen, Inc. · 2006 · 3 generations on0descendants
- K042314Syringe Grip for the Avonex Pre-Filled SyringeBiogen · 2004 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K860284 | Diamatic, Automatic Insulin Injector | Ulster Scientific, Inc. | 1986 | — |
| +1 | K974678 | B-D Auto-Injector | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | — |
| +2 | K032425 | Invisiject Resusable Auto-Injector | Biogen | 2003 | — |
| +2 | K042557 | Innoject Auto-Injector | Innoject, Inc. | 2004 | — |
| +3 | K060389 | Confidose IM Auto-Injector | Pharma-Pen, Inc. | 2006 | — |
| +3 | K042314 | Syringe Grip for the Avonex Pre-Filled Syringe | Biogen | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 9.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K974678 | B-D Auto-Injector | 1998 | 4 |
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, K974678 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1998) has gone furthest, with 4 descendants of its own.
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 | — |
https://510kreport.com/device/K860284 · printed Nov 4, 2026
Cite this page
510(k) Report. “K860284: Diamatic, Automatic Insulin Injector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K860284
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026