510(k) · Cleared
ClearedAccu-Chek Linkassist
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Disetronic Medical Systems AG · KZH Introducer, Syringe Needle
Cleared on Nov 27, 2006 as substantially equivalent to K970479 (Medtronic Minimed, 1997) and 1 other predicate after a 42-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Nov 27, 2006
- Review
- 42 days
- Class
- Class II
- Product code
- KZH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K945660 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945660 | Autoject 2 | Owen Mumford USA, Inc. | 1995 | 3 |
| −1 | K970479 | Minimed Sof-Serter Infusion Set Insertion System, Model 300 | Medtronic Minimed | 1997 | — |
| 0 (this device) | K063146 | Accu-Chek Linkassist | Disetronic Medical Systems AG | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 9.4 · 4 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K970479 | Minimed Sof-Serter Infusion Set Insertion System, Model 300Summary page 2…sist Predicate Devices: The Accu-Chek LinkAssist is substantially equivalent to the following predicate devices: * Sof-Serter by Medironic Minimed; 510(k) number K970479 * Quick-Serter by Medtronic Minimed, 510(k) number K992300 Safety and Effectiveness: The Accu-Chek LinkAssist device and… | 1997 |
| * | K992300 | Quick-Serter, Model 395Summary page 2…ly equivalent to the following predicate devices: * Sof-Serter by Medironic Minimed; 510(k) number K970479 * Quick-Serter by Medtronic Minimed, 510(k) number K992300 Safety and Effectiveness: The Accu-Chek LinkAssist device and the predicate devices, Sof-Serter and Quick- Serter, have the sa… | 1999 |
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 11 years and passes through 3 companies; a new generation was cleared every 9.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
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 Accu-Chek LinkAssist is an insertion device, which is intended specifically
for placement of compatible Accu-Chek infusion sets.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063146 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063146: Accu-Chek Linkassist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063146
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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