510(k) Report

FDA product code · General hospital

Iodinated Contrast Media Transfer Tubing Set

PQHClass II21 CFR 880.5440510(k) required6 decisions since 20140 recalls

6 FDA decisions since 2014. No recall names this code. The most-cited predicate is K133147, named by 2 later devices.

The iodinated contrast media transfer set is intended to transfer iodinated contrast media from imaging bulk package contrast media in a controlled ambient environment. The transfer set is intended to be used to directly fill multiple sterile single use syringes from an imaging bulk package contrast media bulk package under controlled ambient filling conditions such as a CT suite.

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

FIG. A — Illustration, general hospital panel

Twenty years of PQH at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · PQH

2in 2020

2014: 12016: 12018: 12020: 22026 (partial year): 1
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

2021: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20141—00
20150—00
20161—00
20170—00
20181—00
20190—00
20202—00
20210—01
20220—00
20230—00
20240—00
20250—00
20261—0—
FIG. 1 — PQH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PQH? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do PQH devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K133147Bracco Injeenering Transfer SetBracco Injeneering S.A. · 20142cite it
  • K161723ulrich Transfer SetUlrich GmbH & Co. KG · 20161cites it
  • K173913MEDRAD® Imaging Bulk Package Transfer SetBayer U.S., LLC · 20181cites it
  • K200280MEDRAD Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc. · 20201cites it

Which PQH devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K253688MEDRAD® Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc. · 20265generations
  • K193010Liebel-Flarsheim IBP Transfer SetLiebel-Flarsheim Company, LLC · 20204generations
  • K200280MEDRAD Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc. · 20204generations
  • K173913MEDRAD® Imaging Bulk Package Transfer SetBayer U.S., LLC · 20183generations
  • K161723ulrich Transfer SetUlrich GmbH & Co. KG · 20163generations
  • K133147Bracco Injeenering Transfer SetBracco Injeneering S.A. · 20142generations

What has FDA decided in PQH lately?

  • K253688MEDRAD® Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc. · 2026
  • K193010Liebel-Flarsheim IBP Transfer SetLiebel-Flarsheim Company, LLC · 2020
  • K200280MEDRAD Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc. · 2020
  • K173913MEDRAD® Imaging Bulk Package Transfer SetBayer U.S., LLC · 2018
  • K161723ulrich Transfer SetUlrich GmbH & Co. KG · 2016
  • K133147Bracco Injeenering Transfer SetBracco Injeneering S.A. · 2014

All 6 PQH decisions →

Related product codes

Other codes under 21 CFR 880.5440.

POQ Blood Transfusion KitFMG Stopcock, I.V. SetPWQ Buret Administration Intravenous KitOJA Intravenous Extension Tubing SetFPK Tubing, Fluid DeliveryFPA Set, Administration, IntravascularCAK Microfilter, Blood TransfusionNEP System/Device, Pharmacy CompoundingPWH Administrations Sets With Neuraxial ConnectorsMJF Check Valve, Retrograde Flow (In-Line)PYR Neuraxial Administration Set - Intrathecal…LHI Set, I.V. Fluid Transfer