510(k) · Cleared
ClearedMimimed Sil-Serter Infusion Set Insertion System, Model 385
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Minimed, Inc. · KZH Introducer, Syringe Needle
Cleared on Apr 5, 2001 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Apr 5, 2001
- Review
- 56 days
- Class
- Class II
- Product code
- KZH
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK010377 Mimimed Sil-Serter Infusion Set Insertion System, Model 385Minimed, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK061374 Intuition Infusion SetsUnomedical A/S · 2006
- Descendant · 2 generations on · 1 of its ownK242692 SteadiSet Infusion SetCapillary Biomedical, LLC · 2025
- Descendant · 3 generations on · 0 of its ownK251854 SteadiSet infusion setTandem Diabetes Care · 2025
- Descendant · cites it directly · 0 of its ownK213429 AccuSert Needle InserterEmed Technologies Corporation · 2022
Most influential descendants
Showing 4 of 4 · See all- K061374Intuition Infusion SetsUnomedical A/S · 2006 · cites it directly2descendants
- K242692SteadiSet Infusion SetCapillary Biomedical, LLC · 2025 · 2 generations on1descendant
- K251854SteadiSet infusion setTandem Diabetes Care · 2025 · 3 generations on0descendants
- K213429AccuSert Needle InserterEmed Technologies Corporation · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010377 | Mimimed Sil-Serter Infusion Set Insertion System, Model 385 | Minimed, Inc. | 2001 | — |
| +1 | K061374 | Intuition Infusion Sets | Unomedical A/S | 2006 | — |
| +2 | K242692 | SteadiSet Infusion Set | Capillary Biomedical, LLC | 2025 | — |
| +3 | K251854 | SteadiSet infusion set | Tandem Diabetes Care | 2025 | — |
| +1 | K213429 | AccuSert Needle Inserter | Emed Technologies Corporation | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 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 9.3 · 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? (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?
- Of its descendants, K061374 (Unomedical A/S, 2006) 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 | — |
https://510kreport.com/device/K010377 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010377: Mimimed Sil-Serter Infusion Set Insertion System, Model 385.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010377
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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