MEDRAD® Imaging Bulk Package Transfer Spike
FDA 510(k) clearance K253688 · decided 2026-06-12
Clearance details
- K-number
- K253688
- Device name
- MEDRAD® Imaging Bulk Package Transfer Spike
- Applicant
- Bayer Medical Care, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-11-21
- Decision date
- 2026-06-12
- Days to decision
- 203 days
- Clearance type
- Traditional
- Product code
- PQH
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Indianaola, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Liebel-Flarsheim IBP Transfer Set (K193010) | Liebel-Flarsheim Company, LLC | 2020-11-18 |
| MEDRAD Imaging Bulk Package Transfer Spike (K200280) | Bayer Medical Care, Inc. | 2020-07-30 |
| MEDRAD® Imaging Bulk Package Transfer Set (K173913) | Bayer U.S., LLC | 2018-05-04 |
| ulrich Transfer Set (K161723) | Ulrich GmbH & Co. KG | 2016-12-21 |
| BRACCO INJEENERING TRANSFER SET (K133147) | Bracco Injeneering S.A. | 2014-06-20 |
Recalls involving this device
No recalls on record reference this clearance.