# K202672: Precision Delivery Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Quest Medical, Inc.
- Decided: Jan 21, 2021 after 128 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K001901 (2000). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142527: Extension Set with BD Q-Syte Luer Access Split Septum, Acacia, Inc. (2014) Summary page 5.

## Recalls of this device
- Dec 23, 2022 · Class II · Z-1100-2023: Delivery Sets may have tubing that could become detached that could result in patient infection.

## Indications for use
The Precision Delivery Infusion Sets are intended to be used to administer or aspirate fluids. These devices may be used with any patient population with consideration given to the procedure being performed-and fluids being infused.

Source page: https://510kreport.com/device/K202672
Methodology: https://510kreport.com/methodology