# K203135: Medline Vacu-line Suction Aspirator

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: May 4, 2021 after 197 days
- Product code: BTA (Pump, Portable, Aspiration (Manual Or Powered))
- Device class: 2
- Regulation: 21 CFR 878.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K971749 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140179: Easy GO Vac, Precision Medical, Inc. (2014) Summary page 4.

## Indications for use
The Medline Vacu-line Suction Aspirator is a portable, AC-powered device to be used on general patient population excluding neonatal due to pressure range, to supply a vacuum source adequate within the stated operating vacuum range, to aspirate fluids from respiratory airway. Intended use in home care or hospital environments.

Source page: https://510kreport.com/device/K203135
Methodology: https://510kreport.com/methodology