510(k) · Cleared
ClearedTubeClear System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Actuated Medical, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Jun 29, 2018 as substantially equivalent to K163092 (Actuated Medical, Inc., 2016) and 1 other predicate after a 309-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Jun 29, 2018
- Review
- 309 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K905164 (1991). No later device cites it as a predicate yet.
- Root · 5 generations backK905164 Tube DecloggerNova Design Technologies, Ltd. · 1991
- 4 generations backK121571 TubeclearActuated Medical, Inc. · 2012
- 3 generations backK123659 Tube-Clear, Control Box (Component of Tubeclear), Clearing Stem…Actuated Medical, Inc. · 2012
- 2 generations backK131052 Tubeclear Model 101 (with New Clearing Stem NE and G Models)Actuated Medical, Inc. · 2013
- 1 generation backK163092 TubeClear Control Box and Clearing StemActuated Medical, Inc. · 2016
- This deviceK172556 TubeClear SystemActuated Medical, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K905164 | Tube Declogger | Nova Design Technologies, Ltd. | 1991 | — |
| −4 | K121571 | Tubeclear | Actuated Medical, Inc. | 2012 | — |
| −3 | K123659 | Tube-Clear, Control Box (Component of Tubeclear), Clearing Stem (Component of… | Actuated Medical, Inc. | 2012 | — |
| −2 | K131052 | Tubeclear Model 101 (with New Clearing Stem NE and G Models) | Actuated Medical, Inc. | 2013 | — |
| −1 | K163092 | TubeClear Control Box and Clearing Stem | Actuated Medical, Inc. | 2016 | — |
| 0 (this device) | K172556 | TubeClear System | Actuated Medical, Inc. | 2018 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KNT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KNT device
- #1 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K163092 | TubeClear Control Box and Clearing StemSummary page 4…eted devices to which substantial equivalence is being claimed are as follows: 510(k) Number Trade Name Manufacturer K163092 TubeClear System Actuated Medical, Inc. K131052 TubeClear System Actuated Medical,… | 2016 |
| * | K131052 | Tubeclear Model 101 (with New Clearing Stem NE and G Models)Summary page 4…: 510(k) Number Trade Name Manufacturer K163092 TubeClear System Actuated Medical, Inc. K131052 TubeClear System Actuated Medical, Inc.… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K163092.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · KNT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNT
136in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNT
13in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KNT
1,451in 2025
MAUDE reports naming product code KNT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 118 | 1 | 300 |
| 2008 | 10 | 115 | 82 | 867 |
| 2009 | 11 | 102 | 9 | 818 |
| 2010 | 12 | 104 | 3 | 517 |
| 2011 | 7 | 211 | 2 | 531 |
| 2012 | 12 | 107 | 1 | 528 |
| 2013 | 7 | 128 | 0 | 747 |
| 2014 | 16 | 259 | 0 | 1,030 |
| 2015 | 10 | 140 | 1 | 1,048 |
| 2016 | 6 | 99 | 3 | 1,251 |
| 2017 | 9 | 247 | 4 | 1,672 |
| 2018 | 7 | 149 | 2 | 1,901 |
| 2019 | 10 | 126 | 2 | 1,838 |
| 2020 | 5 | 102 | 1 | 1,641 |
| 2021 | 6 | 121 | 2 | 1,655 |
| 2022 | 7 | 110 | 1 (1) | 1,650 |
| 2023 | 5 | 162 | 2 | 1,863 |
| 2024 | 9 | 103 | 0 | 1,344 |
| 2025 | 4 | 136 | 13 | 1,451 |
| 2026 | 3 | 105 | 20 | — |
What is it indicated for?
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…
Read the full statement (467 words)
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172556: TubeClear System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172556
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026