# K884318: Thermoset (TM) Closed Loop Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Dec 13, 1988 after 61 days
- Product code: KRB (Probe, Thermodilution)
- Device class: 2
- Regulation: 21 CFR 870.1915
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Oct 5, 2018 · Class II · Z-0662-2019: Potential for leakage due to defect in the thermoset check valve component.
- Oct 5, 2018 · Class II · Z-0661-2019: Potential for leakage due to defect in the thermoset check valve component.
- Oct 5, 2018 · Class II · Z-0663-2019: Potential for leakage due to defect in the thermoset check valve component.

Source page: https://510kreport.com/device/K884318
Methodology: https://510kreport.com/methodology