510(k) · Cleared

Cleared

MiniMed Quick-serter

K160860510(k) TraditionalCleared Sep 22, 2016177-day reviewClass II21 CFR 880.6920

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic Minimed · KZH Introducer, Syringe Needle

Cleared on Sep 22, 2016 as substantially equivalent to K992300 (Medtronic Minimed, 1999) after a 177-day review. Its family tree reaches back 1 generation to 1999.

Decided: Sep 22, 2016
Review: 177 days
Class: Class II
Product code: KZH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K992300 (1999). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK992300 Quick-Serter, Model 395Medtronic Minimed · 1999
This deviceK160860 MiniMed Quick-serterMedtronic Minimed · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K992300	Quick-Serter, Model 395	Medtronic Minimed	1999	—
0 (this device)	K160860	MiniMed Quick-serter	Medtronic Minimed	2016	—

FIG. 1 — Lineage of K160860, 1999–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K992300	Quick-Serter, Model 395 Summary page 4 …ing Product Branch: General Hospital Devices Branch (GHDB) III. PREDICATE DEVICE [807.92(a)(3)] MiniMed Quick-serter (MMT-395), infusion set insertion system (K992300) Reference Devices • MiniMed Quick-set Infusion Set (K991759, K011071) • MiniMed Pro-set Infusion Set (K160651) Purpose…	Medtronic Minimed	1999	—
†	K991759	Maersk Medical Contour Infusion Set	Maersk Medical A/S	1999	—
†	K011071	Paradigm Quick-Set Infusion Set	Maersk Medical A/S	2001	Class I
†	K160651	BD FlowSmart Set, MiniMed Pro-Set	Becton, Dickinson and Company	2016	2

Also cleared against K992300: 2 other devices →

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?

Its one ancestor has no recall.
2 other devices also cite its predicate K992300.

How does its category compare?

All KZH devices

KZH Introducer, Syringe Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · KZH

1in 2024

2007high 2 (2008) · low 0 (2009)2026

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

2007high 2 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KZH

16in 2025

2007high 158 (2020) · low 0 (2008)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 MiniMed Quick-serter is indicated to use as an aid for inserting compatible devices. It is for use by a single patient. It is not for use by multiple patients.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K160860 · printed Nov 4, 2026

Cite this page

510(k) Report. “K160860: MiniMed Quick-serter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160860

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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