# K121571: Tubeclear

- Pathway: 510(k) (Traditional)
- Applicant: Actuated Medical, Inc.
- Decided: Jun 13, 2012 after 15 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: 1 generation back to K905164 (1991). 1 ancestor in all.
6 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905164: Tube Declogger, Nova Design Technologies, Ltd. (1991) Summary page 1.

## Most influential descendants
- K123659: Tube-Clear, Control Box (Component of Tubeclear), Clearing Stem (Component of Tubeclear) (2012), 4 descendants of its own
- 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
- K180605: GastroFlush (2018), 0 descendants of its own

## Indications for use
TubeClear TM 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/K121571
Methodology: https://510kreport.com/methodology