510(k) · Cleared
ClearedQuick-Serter, Model 395
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Minimed · KZH Introducer, Syringe Needle
Cleared on Jul 29, 1999 after a 21-day review. The FDA summary names its predicate without a number. 1 of the 18 devices in its family, counting itself, has a Class I recall. 17 later devices descend from it.
- Decided
- Jul 29, 1999
- Review
- 21 days
- Class
- Class II
- Product code
- KZH
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 3 citing it directly. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- This deviceK992300 Quick-Serter, Model 395Medtronic Minimed · 1999
- Descendant · cites it directly · 14 of its ownK032854 Unomedical Monica Infusion SetUnomedical A/S · 2003 · Recalled
- Descendant · 2 generations on · 3 of its ownK173879 MiniMed Mio Advance infusion setUnomedical A/S · 2018
- Descendant · 2 generations on · 2 of its ownK061374 Intuition Infusion SetsUnomedical A/S · 2006
- Descendant · 3 generations on · 1 of its ownK243841 Sparta Infusion Set for InsulinDeka Research and Development · 2025
- Descendant · 3 generations on · 1 of its ownK242692 SteadiSet Infusion SetCapillary Biomedical, LLC · 2025
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K162812 Unomedical Comfort Subcutaneous Infusion Set…3 generations on · 2017
Most influential descendants
Showing 5 of 17 · See all- K032854Unomedical Monica Infusion SetUnomedical A/S · 2003 · cites it directly14descendants
- K173879MiniMed Mio Advance infusion setUnomedical A/S · 2018 · 2 generations on3descendants
- K061374Intuition Infusion SetsUnomedical A/S · 2006 · 2 generations on2descendants
- K243841Sparta Infusion Set for InsulinDeka Research and Development · 2025 · 3 generations on1descendant
- K242692SteadiSet Infusion SetCapillary Biomedical, LLC · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992300 | Quick-Serter, Model 395 | Medtronic Minimed | 1999 | — |
| +1 | K032854 | Unomedical Monica Infusion Set | Unomedical A/S | 2003 | 1 |
| +2 | K173879 | MiniMed Mio Advance infusion set | Unomedical A/S | 2018 | — |
| +2 | K061374 | Intuition Infusion Sets | Unomedical A/S | 2006 | — |
| +3 | K243841 | Sparta Infusion Set for Insulin | Deka Research and Development | 2025 | — |
| +3 | K242692 | SteadiSet Infusion Set | Capillary Biomedical, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 1 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | — | MiniMed Sof-serter™ infusion set insertion system Named without a submission number |
What descends from it? (17)
See all 173 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K162812Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical…Unomedical A/S · 2017 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- Of its descendants, K032854 (Unomedical A/S, 2003) has gone furthest, with 14 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 Quick-serter infusion set insertion system (Quick-serter), model 395, is indicated for use as an aid for insertion of the Maersk Medical A/S Contour infusion sets.
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/K992300 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992300: Quick-Serter, Model 395.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992300
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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