510(k) · Cleared
ClearedB-D Auto-Injector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Becton Dickinson Vacutainer Systems Preanalytic · KZH Introducer, Syringe Needle
Cleared on May 29, 1998 as substantially equivalent to K860284 (Ulster Scientific, Inc., 1986) after a 165-day review. Its family tree reaches back 1 generation to 1986. 4 later devices descend from it.
- Decided
- May 29, 1998
- Review
- 165 days
- Class
- Class II
- Product code
- KZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K860284 (1986). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK860284 Diamatic, Automatic Insulin InjectorUlster Scientific, Inc. · 1986
- This deviceK974678 B-D Auto-InjectorBd Becton Dickinson Vacutainer Systems Preanalytic · 1998
- Descendant · cites it directly · 2 of its ownK032425 Invisiject Resusable Auto-InjectorBiogen · 2003
- Descendant · cites it directly · 1 of its ownK042557 Innoject Auto-InjectorInnoject, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK060389 Confidose IM Auto-InjectorPharma-Pen, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK042314 Syringe Grip for the Avonex Pre-Filled SyringeBiogen · 2004
Most influential descendants
Showing 4 of 4 · See all- K032425Invisiject Resusable Auto-InjectorBiogen · 2003 · cites it directly2descendants
- K042557Innoject Auto-InjectorInnoject, Inc. · 2004 · cites it directly1descendant
- K060389Confidose IM Auto-InjectorPharma-Pen, Inc. · 2006 · 2 generations on0descendants
- K042314Syringe Grip for the Avonex Pre-Filled SyringeBiogen · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K860284 | Diamatic, Automatic Insulin Injector | Ulster Scientific, Inc. | 1986 | — |
| 0 (this device) | K974678 | B-D Auto-Injector | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | — |
| +1 | K032425 | Invisiject Resusable Auto-Injector | Biogen | 2003 | — |
| +1 | K042557 | Innoject Auto-Injector | Innoject, Inc. | 2004 | — |
| +2 | K060389 | Confidose IM Auto-Injector | Pharma-Pen, Inc. | 2006 | — |
| +2 | K042314 | Syringe Grip for the Avonex Pre-Filled Syringe | Biogen | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K860284 | Diamatic, Automatic Insulin InjectorSummary page 2…which operate on the same principle. I SUBSTANTIAL EQUIVALENCE The BD Auto-Injector is substantially equivalent to Ulster Scientific Inc.'s Diamatic™ auto- injector, (K860284) which was cleared by FDA in April 1986. The term “ substantial equivalence ” as used in this 510(k) notification is limited to… | 1986 |
What descends from it? (4)
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?
- Its one ancestor has no recall.
- Of its descendants, K032425 (Biogen, 2003) has gone furthest, with 2 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 | — |
What is it indicated for?
The B-D® Auto-Injector is indicated for assisting the injection of a fixed dose of an approved drug or biologic packaged in a HYPAK® Cartridge component which contains a HYPAK® syringe prefilled with the drug or biologic.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974678 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974678: B-D 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/K974678
Report an extraction error
Are you the manufacturer?
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