# K170002: Medline Blood Collection Set

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Sep 19, 2017 after 259 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- 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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Medline Blood Collection Set is intended to be used for insertion into a patient's vascular system for blood collection or short term IV administration (up to 2 hours), under the direct supervision of a trained medical professional. It aids in the prevention of accidental needle stick through the use of an active safety feature.

Source page: https://510kreport.com/device/K170002
Methodology: https://510kreport.com/methodology