# K200646: TubeClear System

- Pathway: 510(k) (Traditional)
- Applicant: Actuated Medical, Inc.
- Decided: Dec 4, 2020 after 267 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K905164 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163092: TubeClear Control Box and Clearing Stem, Actuated Medical, Inc. (2016) Summary page 5.

## Indications for use
TubeClear Clearing Stem Model GJ-1422 is indicated for use ONLY and SOLELY in clearing occlusions/clogs in adults that have the following Tube type and size (French and length). + GJ-1422, for G-Jet®, MIC®, and MIC-KEY® Gastro-jejunostomy tubes that are size 14-22 Fr and have a jejunal length of 15-45 cm (6-18 in).

Source page: https://510kreport.com/device/K200646
Methodology: https://510kreport.com/methodology