# K163092: TubeClear Control Box and Clearing Stem

- Pathway: 510(k) (Traditional)
- Applicant: Actuated Medical, Inc.
- Decided: Nov 30, 2016 after 26 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: 4 generations back to K905164 (1991). 4 ancestors in all.
2 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)
- K131052: Tubeclear Model 101 (with New Clearing Stem NE and G Models), Actuated Medical, Inc. (2013) Summary page 5.

## Most influential descendants
- K200646: TubeClear System (2020), 0 descendants of its own
- K172556: TubeClear System (2018), 0 descendants of its own

## Indications for use
TubeClear Clearing Stem Model TC-1018 is indicated for use ONLY and SOLELY in clearing occlusion / clogs in Feeding and Decompression Tubes in adults that have the following Tube type and size (French and length). * TC-1018, for Nasoenteral and Nasogastric Tubes that are size 10 - 18 Fr and have a length of 91 - 140 cm (36 - 55 in); and Gastrostomy and Jejunostomy Tubes that are size 10 - 18 Fr and have a length of 20 - 36 cm (8 - 14 in). TubeClear Clearing Stem Model TC-0812 is indicated for use ONLY and SOLELY in clearing occlusion / clogs in Feeding and Decompression Tubes in adults that have the following Tube type, size (French and length), and material. » TC-0812, for Nasoenteral and Nasogastric Tubes composed of Polyvinyl Chloride (PVC) and Polyurethane that are size 8 - 12 Fr and have a length of 38 - 140 cm (15 - 55 in). TubeClear Clearing Stem Model TC-0608 is indicated for use ONLY and SOLELY in clearing occlusion / clogs in Feeding and Decompression Tubes in adults that have the following Tube type, size (French and length), and material. » TC-0608, for Nasoenteral and Nasogastric Tubes composed of Polyvinyl Chloride (PVC) and Polyurethane that are size 6 - 8 Fr and have a length of 38 -140 cm (15 - 55 in).

Source page: https://510kreport.com/device/K163092
Methodology: https://510kreport.com/methodology