# K172556: TubeClear System

- Pathway: 510(k) (Traditional)
- Applicant: Actuated Medical, Inc.
- Decided: Jun 29, 2018 after 309 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 4.
- K131052: Tubeclear Model 101 (with New Clearing Stem NE and G Models), Actuated Medical, Inc. (2013) Summary page 4.

## Indications for use
TubeClear System Clearing Stem Models are indicated for use ONLY and SOLELY in clearing occlusions/clogs in Feeding and Decompression Tubes in adult patients that have the following Tube type and size (French and length): • 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); • 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); • 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); • 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 and 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 - 18 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 Jejunostomy Tubes that are of size 10 - 18 Fr and have a length of 30 cm (12 in); and • G-1014: for Gastrostomy 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/K172556
Methodology: https://510kreport.com/methodology