# K922637: Horizon Pump Y-Type Blood Set

- Pathway: 510(k) (Traditional)
- Applicant: Mcgaw, Inc.
- Decided: Jun 4, 1993 after 365 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 1 cites it directly.
6 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K972678: Millennium CRT Infusion Pump and Millennium CRT Infusion Pump Administration Sets (1997), 16 descendants of its own
- K062700: Infusomat Space Volumetric Infusion Pump System (2006), 15 descendants of its own
- K140838: IV Administration Set with Hand Pump (2014), 6 descendants of its own
- K083689: Infusomat Space Volumetric Infusion Pump System (2009), 4 descendants of its own
- K170595: IV Administration Sets (2017), 3 descendants of its own

## Recalls of this device
- Oct 29, 2025 · Class II · Z-0618-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0619-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0620-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Aug 10, 2021 · Class II · Z-2553-2021: Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- Aug 10, 2021 · Class II · Z-2548-2021: Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- Aug 10, 2021 · Class II · Z-2559-2021: Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- Aug 10, 2021 · Class II · Z-2560-2021: Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- Nov 20, 2019 · Class II · Z-0935-2020: Potential for leakage at the joint between the blood filters and tubing
- Nov 20, 2019 · Class II · Z-0939-2020: Potential for leakage at the joint between the blood filters and tubing
- Nov 20, 2019 · Class II · Z-0937-2020: Potential for leakage at the joint between the blood filters and tubing
- Nov 24, 2009 · Not classified · Z-0718-2010: System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initi

Source page: https://510kreport.com/device/K922637
Methodology: https://510kreport.com/methodology