# K171954: ClearLine IV

- Pathway: 510(k) (Traditional)
- Applicant: Clearline MD
- Decided: Jan 25, 2018 after 210 days
- Product code: OKL (Intravascular Administration Set, Automated Air Removal System)
- Device class: 2
- Regulation: 21 CFR 880.5445
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN080009 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN080009: Airpurge, Anesthesia Safety Products, LLC (2014) Summary page 4.

## Indications for use
ClearLine IV™ is intended for detection and automatic removal of air in intravenous (IV) lines during administration of IV solutions, blood, and blood products. It is indicated for use in critical care areas such as the operating room (OR), post-anesthesia care unit (PACU), and intensive care unit (ICU). ClearLine IV™ is placed between the patient and the IV source and can be used with or without fluid warmers.

Source page: https://510kreport.com/device/K171954
Methodology: https://510kreport.com/methodology