# K780880: Y-Type Blood Set

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 30, 1978 after 31 days
- Product code: KDC (Instrument, Surgical, Disposable)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
31 later devices descend from it; 1 cites it directly.
5 of 32 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
- K101677: Hospira Infusion Blood Sets (2010), 30 descendants of its own
- K113683: Lifeshield Vision Infusion Set with Pre-Pierced Reseal (2012), 19 descendants of its own
- K141789: Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for Plum a+ Infusion System Upgrade (2015), 9 descendants of its own
- K140838: IV Administration Set with Hand Pump (2014), 6 descendants of its own
- K161469: Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module (2017), 5 descendants of its own

## Recalls of this device
- Mar 28, 2011 · Not classified · Z-2025-2011: There is a potential for the air filter at the distal end of the set to become detached. This could result in the contamination of the sterile fluid path inside the tubing.
- Mar 28, 2011 · Not classified · Z-2026-2011: There is a potential for the air filter at the distal end of the set to become detached. This could result in the contamination of the sterile fluid path inside the tubing.
- Mar 28, 2011 · Not classified · Z-2024-2011: There is a potential for the air filter at the distal end of the set to become detached. This could result in the contamination of the sterile fluid path inside the tubing.
- Nov 24, 2009 · Not classified · Z-1392-2010: Reports of difficulty in adjusting the flow rate, which could result in flow rate variances.

Source page: https://510kreport.com/device/K780880
Methodology: https://510kreport.com/methodology