FDA product code PQH: Iodinated Contrast Media Transfer Tubing Set
PQH is the FDA product code for iodinated contrast media transfer tubing set. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel. FDA has cleared 6 510(k) submissions under PQH, 1 in the last five years, from 5 different applicants. The average 510(k) review took 221 days (median 192); 203 days on average over the last three years.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Iodinated Contrast Media Transfer Tubing Set |
| Device class | Class II |
| Regulation | 21 CFR 880.5440 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for PQH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 133 |
| 2020 | 2 | 282 |
| 2026 | 1 | 203 |
Compare with all 510(k) review times · Search every PQH clearance
Top PQH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bayer Medical Care, Inc. | 2 | 2026-06-12 |
| Liebel-Flarsheim Company, LLC | 1 | 2020-11-18 |
| Bayer U.S., LLC | 1 | 2018-05-04 |
| Ulrich GmbH & Co. KG | 1 | 2016-12-21 |
| Bracco Injeneering S.A. | 1 | 2014-06-20 |
Most recent PQH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253688 | Bayer Medical Care, Inc. | MEDRAD® Imaging Bulk Package Transfer Spike | 2026-06-12 | 203 |
| K193010 | Liebel-Flarsheim Company, LLC | Liebel-Flarsheim IBP Transfer Set | 2020-11-18 | 386 |
| K200280 | Bayer Medical Care, Inc. | MEDRAD Imaging Bulk Package Transfer Spike | 2020-07-30 | 177 |
| K173913 | Bayer U.S., LLC | MEDRAD® Imaging Bulk Package Transfer Set | 2018-05-04 | 133 |
| K161723 | Ulrich GmbH & Co. KG | ulrich Transfer Set | 2016-12-21 | 182 |
Recalls for PQH devices
openFDA lists no recalls for product code PQH.
Frequently asked questions
What is FDA product code PQH?
PQH is the FDA product code for iodinated contrast media transfer tubing set. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel.
What device class is PQH?
Class II, regulation 21 CFR 880.5440. Typical premarket route: 510(k).
How long does a 510(k) take for product code PQH?
Across 6 cleared submissions the average was 221 days from receipt to decision (median 192).
Which companies have the most PQH clearances?
Bayer Medical Care, Inc. (2); Liebel-Flarsheim Company, LLC (1); Bayer U.S., LLC (1); Ulrich GmbH & Co. KG (1); Bracco Injeneering S.A. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PQH
- Run a recall and safety report across every PQH manufacturer
- Watch product code PQH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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