510(k) · Cleared

Cleared

Safetouch PSV Winged Infusion Set, and Set with Filter

K113429510(k) SpecialCleared Mar 12, 2012112-day reviewClass II21 CFR 880.5200

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

Nipro Medical Corporation · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Cleared on Mar 12, 2012 as substantially equivalent to K011297 (Nipro Medical Corp., 2001) after a 112-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: Mar 12, 2012
Review: 112 days
Class: Class II
Product code: FOZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011297 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK011297 Nipro Safetouch Scalp Vein and Blood Collection SetNipro Medical Corp. · 2001 · Recalled
This deviceK113429 Safetouch PSV Winged Infusion Set, and Set with FilterNipro Medical Corporation · 2012
Descendant · cites it directly · 0 of its ownK132153 Safetouch PSV Winged Infusion Set with/Without FilterNipro Medical Corporation · 2013

Most influential descendants

Showing 1 of 1 · See all

K132153Safetouch PSV Winged Infusion Set with/Without FilterNipro Medical Corporation · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011297	Nipro Safetouch Scalp Vein and Blood Collection Set	Nipro Medical Corp.	2001	1
0 (this device)	K113429	Safetouch PSV Winged Infusion Set, and Set with Filter	Nipro Medical Corporation	2012	—
+1	K132153	Safetouch PSV Winged Infusion Set with/Without Filter	Nipro Medical Corporation	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0

FIG. 1 — Lineage of K113429, 2001–2013Source: 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 FOZ? 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 FOZ device

#1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 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
*	K011297	Nipro Safetouch Scalp Vein and Blood Collection Set Summary page 1 …s Regulation Number: 21 CFR 880.5200 Panel: 80 Product Code: FOZ 807.9 2(a)(3) Legally marketed substantial equivalent device: K011297 - NIPRO SafeTouch Scalp Vein Set and Blood Collection Needle 807.92(a)(4) Description of device: The SafeTouch P…	Nipro Medical Corp.	2001	1

Also cleared against K011297: 2 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
K132153	Safetouch PSV Winged Infusion Set with/Without Filter	Nipro Medical Corporation	2013	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, K132153 (Nipro Medical Corporation, 2013) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K011297.

How does its category compare?

All FOZ devices

FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · FOZ

11in 2025

2007high 13 (2012) · low 1 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FOZ

91in 2025

2007high 242 (2021) · low 28 (2010)2026

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

Recalls per year · FOZ

4in 2023

2007high 115 (2010) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · FOZ

5,110in 2025

2007high 5,110 (2025) · low 370 (2010)2025

MAUDE reports naming product code FOZ, 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	6	159	16	374
2008	9	103	0	422
2009	9	30	23	508
2010	3	28	115	370
2011	6	132	0	786
2012	13	122	0	560
2013	4	104	2	640
2014	9	99	4	815
2015	10	107	0	729
2016	9	63	3 (1)	925
2017	9	51	22	1,966
2018	1	—	4	3,305
2019	8	140	3	4,365
2020	10	191	3	3,797
2021	4	242	1	4,674
2022	8	183	4 (2)	4,133
2023	9	129	4 (2)	4,430
2024	6	190	0	4,772
2025	11	91	0	5,110
2026	7	203	2	—

What is it indicated for?

The SafeTouch PSV Winged Infusion Set with/without filter is intended to be used for insertion into a patient's vascular system for single use as an indwelling device to administer fluids intravenously or to sample blood. Secondly it is designed with an active sharp feature that requires physical action by the clinician to prevent accidental needlesticks.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K113429 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113429: Safetouch PSV Winged Infusion Set, and Set with Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113429

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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