510(k) · Cleared
ClearedTubeclear Model 101 (with New Clearing Stem NE and G Models)
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 Aug 16, 2013 as substantially equivalent to K121571 (Actuated Medical, Inc., 2012) and 1 other predicate after a 123-day review. Its family tree reaches back 3 generations to 1991. 3 later devices descend from it.
- Decided
- Aug 16, 2013
- Review
- 123 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K905164 (1991). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK905164 Tube DecloggerNova Design Technologies, Ltd. · 1991
- 2 generations backK121571 TubeclearActuated Medical, Inc. · 2012
- 1 generation backK123659 Tube-Clear, Control Box (Component of Tubeclear), Clearing Stem…Actuated Medical, Inc. · 2012
- This deviceK131052 Tubeclear Model 101 (with New Clearing Stem NE and G Models)Actuated Medical, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK163092 TubeClear Control Box and Clearing StemActuated Medical, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK200646 TubeClear SystemActuated Medical, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK172556 TubeClear SystemActuated Medical, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K905164 | Tube Declogger | Nova Design Technologies, Ltd. | 1991 | — |
| −2 | K121571 | Tubeclear | Actuated Medical, Inc. | 2012 | — |
| −1 | K123659 | Tube-Clear, Control Box (Component of Tubeclear), Clearing Stem (Component of… | Actuated Medical, Inc. | 2012 | — |
| 0 (this device) | 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 | — |
| +2 | K200646 | TubeClear System | Actuated Medical, Inc. | 2020 | — |
| +1 | K172556 | TubeClear System | Actuated Medical, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
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 |
|---|---|---|---|
| * | K121571 | TubeclearSummary page 2…ally marketed device to which substantial equivalence is being claimed: 510O(K) Trade or Proprietary Manufacturer Comment Number Name K121571 TubeClear Actuated Medical, Original and Inc.… | 2012 |
| * | K123659 | Tube-Clear, Control Box (Component of Tubeclear), Clearing Stem (Component of Tubeclear)Summary page 2…510OK Cleared 6/18/12 K123659 TubeClear Actuated Medical, Special Inc.… | 2012 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K163092 (Actuated Medical, Inc., 2016) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K121571.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 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).…
Read the full statement (335 words)
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131052 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131052: Tubeclear Model 101 (with New Clearing Stem NE and G Models).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131052
Report an extraction error
Are you the manufacturer?
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