510(k) · Cleared
ClearedSyringe Grip for the Avonex Pre-Filled Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Nov 22, 2004 as substantially equivalent to K032425 (Biogen, 2003) and 1 other predicate after an 88-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Nov 22, 2004
- Review
- 88 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K860284 (1986). 6 ancestors in all, the oldest K820164 (1982). 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 deviceK042314 Syringe Grip for the Avonex Pre-Filled SyringeBiogen · 2004
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) | K042314 | Syringe Grip for the Avonex Pre-Filled Syringe | Biogen | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 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 FMF? 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K032425 | Invisiject Resusable Auto-InjectorSummary page 1…tial Equivalence: Substantial Equivalence: The Syringe Grip for the AVONEX pre-filled syringe is substantially equivalent to the Invisiject reusable auto-injector (K032425) and the Carpuject syringe holder (K820164). 8.6 Description: The Syringe Grip for the AVONEX pre-filled syringe is a reu… | 2003 |
| * | K820164 | Empty Sterile CarpujectSummary page 1…ringe Grip for the AVONEX pre-filled syringe is substantially equivalent to the Invisiject reusable auto-injector (K032425) and the Carpuject syringe holder (K820164). 8.6 Description: The Syringe Grip for the AVONEX pre-filled syringe is a reusable, grip/handle that is designed to assi… | 1982 |
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 18 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 1 other device also cites its predicate K032425.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
The Syringe Grip for the AVONEX prefilled syringe is a reusable device indicated for use by the patient to assist with the self-administered injection of a fixed dose of AVONEX from a prefilled syringe through a single lumen hypodermic needle. The devices are intended to be used in any setting including the home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042314 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042314: Syringe Grip for the Avonex Pre-Filled Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042314
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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