510(k) · Cleared

Cleared

ulrich Transfer Set

K161723510(k) TraditionalCleared Dec 21, 2016182-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

Ulrich GmbH & Co. KG · PQH Iodinated Contrast Media Transfer Tubing Set

Cleared on Dec 21, 2016 as substantially equivalent to K133147 (Bracco Injeneering S.A., 2014) after a 182-day review. Its family tree reaches back 3 generations to 1979. 1 later device descends from it.

Decided: Dec 21, 2016
Review: 182 days
Class: Class II
Product code: PQH
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K791131 (1979). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 3 generations backK791131 Flu Ven TR-1Venospital, Inc. · 1979
2 generations backK041178 Empower Transfer Set, (Cat. NO. 7725)E-Z-Em, Inc. · 2004
1 generation backK133147 Bracco Injeenering Transfer SetBracco Injeneering S.A. · 2014
This deviceK161723 ulrich Transfer SetUlrich GmbH & Co. KG · 2016
Descendant · cites it directly · 0 of its ownK193010 Liebel-Flarsheim IBP Transfer SetLiebel-Flarsheim Company, LLC · 2020

Most influential descendants

Showing 1 of 1 · See all

K193010Liebel-Flarsheim IBP Transfer SetLiebel-Flarsheim Company, LLC · 2020 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K791131	Flu Ven TR-1	Venospital, Inc.	1979	—
−2	K041178	Empower Transfer Set, (Cat. NO. 7725)	E-Z-Em, Inc.	2004	—
−1	K133147	Bracco Injeenering Transfer Set	Bracco Injeneering S.A.	2014	—
0 (this device)	K161723	ulrich Transfer Set	Ulrich GmbH & Co. KG	2016	—
+1	K193010	Liebel-Flarsheim IBP Transfer Set	Liebel-Flarsheim Company, LLC	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2020	1	0

FIG. 1 — Lineage of K161723, 1979–2020Source: 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 PQH? 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 PQH device

#1 K253688 MEDRAD® Imaging Bulk Package Transfer Spikescore 12.7 · 5 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
*	K133147	Bracco Injeenering Transfer Set Summary page 4 …jeneering Transfer Set Common Name: Intravascular Administration Set 510(k) Submitter / Holder Bracco Injeneering S.A. 510(k) Number K133147 Classification: Class II Regulation Number: 21 CFR 880.5440, Intravascular Administration Set Classifica…	Bracco Injeneering S.A.	2014	—
†	K002689	Swabsite Swabbable Valve, Model 245000	Quest Medical, Inc.	2001	—

Also cleared against K133147: 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
K193010	Liebel-Flarsheim IBP Transfer Set	Liebel-Flarsheim Company, LLC	2020	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?

The line of descent spans 37 years and passes through 4 companies; a new generation was cleared every 9.9 years on median.
None of the 3 ancestors has a recall.
Of its descendants, K193010 (Liebel-Flarsheim Company, LLC, 2020) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K133147.

How does its category compare?

All PQH devices

PQH Iodinated Contrast Media Transfer Tubing Set: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · PQH

2in 2020

2007high 2 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PQH

Too few PQH 510(k)s in any year since 2007 to give a median.

Recalls per year · PQH

No recall names PQH since 2007.

Adverse event reports per year · PQH

1in 2021

2007high 1 (2021) · low 0 (2007)2025

MAUDE reports naming product code PQH, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	1	—	0
2015	0	—	0
2016	1	—	0
2017	0	—	0
2018	1	—	0
2019	0	—	0
2020	2	—	0
2021	0	—	1
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	1	—	—

What is it indicated for?

The ulrich Transfer Set is indicated for the transfer of OmnipaqueTM (Iohexol) contrast media as supplied in an Imaging Bulk Package to non pre-filled single-use only sterile syringes on syringe-based contrast injection systems indicated for the controlled, automatic administration on the venous side of contrast media for CT procedures. The Transfer Set is to be discarded after the contrast media container has been depleted or 8 hours have elapsed since the container was penetrated, whichever occurs first.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K161723 · printed Nov 6, 2026

Cite this page

510(k) Report. “K161723: ulrich Transfer Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161723

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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