# K123659: Tube-Clear, Control Box (Component of Tubeclear), Clearing Stem (Component of Tubeclear)

- Pathway: 510(k) (Special)
- Applicant: Actuated Medical, Inc.
- Decided: Dec 20, 2012 after 22 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: 2 generations back to K905164 (1991). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121571: Tubeclear, Actuated Medical, Inc. (2012) Summary page 2.

## Most influential descendants
- K131052: Tubeclear Model 101 (with New Clearing Stem NE and G Models) (2013), 3 descendants of its own
- K163092: TubeClear Control Box and Clearing Stem (2016), 2 descendants of its own
- K200646: TubeClear System (2020), 0 descendants of its own
- K172556: TubeClear System (2018), 0 descendants of its own

## Indications for use
TubeClear is indicated for use only and solely in clearing occlusions / clogs in nasogastric (NG) tubes (i.e., tubes that are placed through the nose and reside in the stomach) of adult patients. Clearing Stem Model NG-1036 is indicated for use in nasogastric tubes that are of size 10 - 14 French and have a length of 36 -42 inches (91 - 108 cm). Clearing Stem Model NG-1043 is indicated for use in nasogastric tubes that are of size 10 - 18 French and have a length of 43 - 50 inches (109 - 127 cm).

Source page: https://510kreport.com/device/K123659
Methodology: https://510kreport.com/methodology