510(k) · Cleared

Cleared

Minimed Sof-Serter Infusion Set Insertion System, Model 300

K970479510(k) TraditionalCleared Mar 31, 199752-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 Mar 31, 1997 as substantially equivalent to K945660 (Owen Mumford USA, Inc., 1995) after a 52-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.

Decided: Mar 31, 1997
Review: 52 days
Class: Class II
Product code: KZH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K945660 (1995). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK945660 Autoject 2Owen Mumford USA, Inc. · 1995 · Recalled
This deviceK970479 Minimed Sof-Serter Infusion Set Insertion System, Model 300Medtronic Minimed · 1997
Descendant · cites it directly · 0 of its ownK063146 Accu-Chek LinkassistDisetronic Medical Systems AG · 2006

Most influential descendants

Showing 1 of 1 · See all

K063146Accu-Chek LinkassistDisetronic Medical Systems AG · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K945660	Autoject 2	Owen Mumford USA, Inc.	1995	3
0 (this device)	K970479	Minimed Sof-Serter Infusion Set Insertion System, Model 300	Medtronic Minimed	1997	—
+1	K063146	Accu-Chek Linkassist	Disetronic Medical Systems AG	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

FIG. 1 — Lineage of K970479, 1995–2006Source: 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 9.4 · 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
*	K945660	Autoject 2 Summary page 1 …ory Affairs (818) 362-5958, 3011 (520) 527-0107 (v/f) Name of Device: MiniMed Sof-serter™ infusion set insertion system. Predicate Device: AutoJect® 2 injection device (K945660). Description of the New Device: The MiniMed Sof-serter infusion set insertion system is a manually operated, spring-loaded inje…	Owen Mumford USA, Inc.	1995	3

Also cleared against K945660: 4 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K063146	Accu-Chek Linkassist	Disetronic Medical Systems AG	2006	0

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 a recall.
Of its descendants, K063146 (Disetronic Medical Systems AG, 2006) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K945660.

How does its category compare?

All KZH devices

KZH Introducer, Syringe Needle: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 Sof-serter infusion set insertion system is intended to help make insertion of a Sof-set or Sof-set QR infusion set simpler and with minimal discomfort. Use of the device may improve the user’s consistency of infusion set insertion.

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/K970479 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970479: Minimed Sof-Serter Infusion Set Insertion System, Model 300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970479

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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