# K840212: Concentrated Platelet Admin. Set

- Pathway: 510(k) (Traditional)
- Applicant: American Mcgaw
- Decided: Mar 6, 1984 after 47 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 8 (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-0616-2026: 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-0617-2026: 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).
- Nov 20, 2019 · Class II · Z-0936-2020: 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 20, 2019 · Class II · Z-0938-2020: Potential for leakage at the joint between the blood filters and tubing
- Nov 20, 2019 · Class II · Z-0940-2020: Potential for leakage at the joint between the blood filters and tubing

Source page: https://510kreport.com/device/K840212
Methodology: https://510kreport.com/methodology