# K131052: Tubeclear Model 101 (with New Clearing Stem NE and G Models)

- Pathway: 510(k) (Traditional)
- Applicant: Actuated Medical, Inc.
- Decided: Aug 16, 2013 after 123 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: 3 generations back to K905164 (1991). 3 ancestors in all.
3 later devices descend from it; 2 cite 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.
- K123659: Tube-Clear, Control Box (Component of Tubeclear), Clearing Stem (Component of Tubeclear), Actuated Medical, Inc. (2012) Summary page 2.

## Most influential descendants
- 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 Feeding and Decompression Tubes in adult patients that have a Tube of size 10 to 18 Fr. The Clearing Stem Models are indicated for use as follows: NE-1036, for Nasoenteral and Nasogastric Tubes that are of size 10 - 18 Fr and have a length of 91 cm (36 in). NE-1042, for Nasoenteral end Nasogastric Tubes that are of size 10 - 18 Fr and have a length of 107 cm (42 in). NE-1043, for Nasoenteral and Nasogastric Tubes that are of size 10 - 18 Fr and have a length of 109 cm (43 in). NE-1045, for Nasoenteral and Nasogastric Tubes that are of size 10- 18 Fr and have a length of 114 cm (45 in). NE-1048, for Nasoenteral and Nasogastric Tubes that are of size 10 -18 Fr and have a length of 122 cm (48 in). NE-1050, for Nasoenteral and Nasogastric Tubes that are of size 10- 18 Fr and have a length of 127 cm (50 in). NE-1055, for Nasoenteral and Nasogastric Tubes that are of size 10 - 18 Fr and have a length of 140 cm (55 in). G-1008, for Gastrostomy and Jejunostomy Tubes that are of size 10- 16 Fr and have a length of 20 cm (8 in). G-1009, for Gastrostomy and Jejunostomy Tubes that are of size 10- 18 Fr and have a length of 23 cm (9 in). G-1010, for Gastrostomy and Jejunostomy Tubes that are of size 10 - 18 Fr and have a length of 25 cm (10 in). G-1011, for Gastrostomy and Jejunostomy Tubes that are of size 10 - 18 Fr and have a length of 28 cm (11 in). G-1012, for Gastrostomy and Jejunostomny Tubes that are of size 10 - 18 Fr and have a length of 30 cm (12 in). G-1014, for Gastrostomny and Jejunostomy Tubes that are of size 10 - 18 Fr and have a length of 36 cm (14 in).

Source page: https://510kreport.com/device/K131052
Methodology: https://510kreport.com/methodology