510(k) · Cleared
ClearedLiebel-Flarsheim IBP Transfer Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Liebel-Flarsheim Company, LLC · PQH Iodinated Contrast Media Transfer Tubing Set
Cleared on Nov 18, 2020 as substantially equivalent to K161723 (Ulrich GmbH & Co. KG, 2016) after a 386-day review. Its family tree reaches back 4 generations to 1979.
- Decided
- Nov 18, 2020
- Review
- 386 days
- Class
- Class II
- Product code
- PQH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K791131 (1979). No later device cites it as a predicate yet.
- Root · 4 generations backK791131 Flu Ven TR-1Venospital, Inc. · 1979
- 3 generations backK041178 Empower Transfer Set, (Cat. NO. 7725)E-Z-Em, Inc. · 2004
- 2 generations backK133147 Bracco Injeenering Transfer SetBracco Injeneering S.A. · 2014
- 1 generation backK161723 ulrich Transfer SetUlrich GmbH & Co. KG · 2016
- This deviceK193010 Liebel-Flarsheim IBP Transfer SetLiebel-Flarsheim Company, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K791131 | Flu Ven TR-1 | Venospital, Inc. | 1979 | — |
| −3 | K041178 | Empower Transfer Set, (Cat. NO. 7725) | E-Z-Em, Inc. | 2004 | — |
| −2 | K133147 | Bracco Injeenering Transfer Set | Bracco Injeneering S.A. | 2014 | — |
| −1 | K161723 | ulrich Transfer Set | Ulrich GmbH & Co. KG | 2016 | — |
| 0 (this device) | K193010 | Liebel-Flarsheim IBP Transfer Set | Liebel-Flarsheim Company, LLC | 2020 | — |
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
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 | Decided |
|---|---|---|---|
| * | K161723 | ulrich Transfer SetSummary page 4…ital Product Code: PQH (Iodinated Contrast Media Transfer Tubing Set) Predicate Device Trade Name: ulrich Transfer Set K Number: K161723 Common Name: Iodinated Contrast Media Transfer Set Classification: Class II Regulation: 21 CFR 880.… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 41 years and passes through 5 companies; a new generation was cleared every 9.9 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All PQH devicesPQH Iodinated Contrast Media Transfer Tubing Set: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · PQH
2in 2020
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Liebel-Flarsheim™ IBP Transfer Set is indicated for the transfer of Optiray® (Ioversol) Imaging Bulk Package contrast media to empty, single-use only, sterile syringes on syringe based contrast injection systems indicated for the controlled, automatic intra-vascular administration of radiopaque contrast agents for their indicated procedures. The IBP Transfer Set is to be discarded after the contrast media container has been emptied or after 12 hours have elapsed since the container was penetrated, whichever occurs first.
Contra-indications for the use of this device are determined by the prescribing physician at the time of use based upon the contrast media package inserts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193010 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193010: Liebel-Flarsheim IBP 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/K193010
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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