510(k) · Cleared

Cleared

K-Shield Advantage Port Access Infusion Set (Pais)

K123344510(k) TraditionalCleared Mar 7, 2013127-day reviewClass II21 CFR 880.5440

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

Kawasumi Laboratories, Inc. · FPA Set, Administration, Intravascular

Cleared on Mar 7, 2013 as substantially equivalent to K060580 (Kawasumi Laboratories, Inc., 2006) after a 127-day review. Its family tree reaches back 1 generation to 2006. 1 later device descends from it.

Decided: Mar 7, 2013
Review: 127 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K060580 (2006). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK060580 K-Shield Port Access Infusion SetKawasumi Laboratories, Inc. · 2006
This deviceK123344 K-Shield Advantage Port Access Infusion Set (Pais)Kawasumi Laboratories, Inc. · 2013
Descendant · cites it directly · 0 of its ownK190233 K-Shield Advantage Port Access Infusion Set (PAIS)Kawasumi Laboratories, Inc. · 2019

Most influential descendants

Showing 1 of 1 · See all

K190233K-Shield Advantage Port Access Infusion Set (PAIS)Kawasumi Laboratories, Inc. · 2019 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K060580	K-Shield Port Access Infusion Set	Kawasumi Laboratories, Inc.	2006	—
0 (this device)	K123344	K-Shield Advantage Port Access Infusion Set (Pais)	Kawasumi Laboratories, Inc.	2013	—
+1	K190233	K-Shield Advantage Port Access Infusion Set (PAIS)	Kawasumi Laboratories, Inc.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0

FIG. 1 — Lineage of K123344, 2006–2019Source: 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 FPA? 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 FPA device

#1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) 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	Applicant	Decided	Recalls
*	K060580	K-Shield Port Access Infusion Set Summary page 1 …ess Infusion Set (PAlS) is substantially equivalent in both function and use to the predicate device, Kawasumi Port Access Infusion Set with Anti Needle Stick Protector (K060580 cleared on 06/06/2006). The predicate is a legally marketed device with the same product code as the proposed device. === Page 2…	Kawasumi Laboratories, Inc.	2006	—

Also cleared against K060580: 1 other device →

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
K190233	K-Shield Advantage Port Access Infusion Set (PAIS)	Kawasumi Laboratories, Inc.	2019	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 no recall.
Of its descendants, K190233 (Kawasumi Laboratories, Inc., 2019) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K060580.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · FPA

11in 2025

2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007high 340 (2023) · low 75 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FPA

98in 2025

2007high 166 (2009) · low 1 (2021)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · FPA

34,506in 2025

2007high 47,210 (2024) · low 1,499 (2007)2025

MAUDE reports naming product code FPA, 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	16	75	17	1,499
2008	18	89	15	1,941
2009	10	166	166	2,512
2010	23	120	58	2,537
2011	12	87	28	4,407
2012	21	96	16 (4)	4,930
2013	13	90	64	4,651
2014	22	89	24	4,695
2015	17	123	6	6,625
2016	12	195	10	8,470
2017	17	240	13	6,462
2018	4	177	4	6,574
2019	7	161	13	11,227
2020	10	327	107	9,563
2021	13	186	1	10,414
2022	14	213	9 (5)	13,393
2023	14	340	12 (4)	10,916
2024	7	244	13 (1)	47,210
2025	11	225	98 (1)	34,506
2026	5	266	10 (2)	—

What is it indicated for?

The devices are used to administer solutions to a surgically implanted part.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123344 · printed Nov 5, 2026

Cite this page

510(k) Report. “K123344: K-Shield Advantage Port Access Infusion Set (Pais).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123344

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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