510(k) · Cleared
ClearedTube-Clear, Control Box (Component of Tubeclear), Clearing Stem (Component of Tubeclear)
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 Dec 20, 2012 as substantially equivalent to K121571 (Actuated Medical, Inc., 2012) after a 22-day review. Its family tree reaches back 2 generations to 1991. 4 later devices descend from it.
- Decided
- Dec 20, 2012
- Review
- 22 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K905164 (1991). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK905164 Tube DecloggerNova Design Technologies, Ltd. · 1991
- 1 generation backK121571 TubeclearActuated Medical, Inc. · 2012
- This deviceK123659 Tube-Clear, Control Box (Component of Tubeclear), Clearing Stem…Actuated Medical, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK131052 Tubeclear Model 101 (with New Clearing Stem NE and G Models)Actuated Medical, Inc. · 2013
- Descendant · 2 generations on · 2 of its ownK163092 TubeClear Control Box and Clearing StemActuated Medical, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK200646 TubeClear SystemActuated Medical, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK172556 TubeClear SystemActuated Medical, Inc. · 2018
Most influential descendants
Showing 4 of 4 · See all- K131052Tubeclear Model 101 (with New Clearing Stem NE and G Models)Actuated Medical, Inc. · 2013 · cites it directly3descendants
- K163092TubeClear Control Box and Clearing StemActuated Medical, Inc. · 2016 · 2 generations on2descendants
- K200646TubeClear SystemActuated Medical, Inc. · 2020 · 3 generations on0descendants
- K172556TubeClear SystemActuated Medical, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K905164 | Tube Declogger | Nova Design Technologies, Ltd. | 1991 | — |
| −1 | K121571 | Tubeclear | Actuated Medical, Inc. | 2012 | — |
| 0 (this device) | K123659 | Tube-Clear, Control Box (Component of Tubeclear), Clearing Stem (Component of… | Actuated Medical, Inc. | 2012 | — |
| +1 | K131052 | Tubeclear Model 101 (with New Clearing Stem NE and G Models) | Actuated Medical, Inc. | 2013 | — |
| +2 | K163092 | TubeClear Control Box and Clearing Stem | Actuated Medical, Inc. | 2016 | — |
| +3 | K200646 | TubeClear System | Actuated Medical, Inc. | 2020 | — |
| +2 | K172556 | TubeClear System | Actuated Medical, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 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? (1)
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…Attachment 4, Pg. 1 of 4 -Wi 4.3 PREDICATE DEVICE TubeClear, manufactured by Actuated Medical, Inc. (AMI) and cleared under 510(k) K121571, is the Predicate Device. TubeClear is composed of a reusable Control Box and single use Clearing Stem. One Control Box model, Mo… | 2012 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131052 | Tubeclear Model 101 (with New Clearing Stem NE and G Models) | 2013 | 3 |
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 21 years and passes through 2 companies; a new generation was cleared every 21.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K131052 (Actuated Medical, Inc., 2013) has gone furthest, with 3 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. 2012, 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 nasogastric (NG) tubes (i.e., tubes that are placed through the nose and reside in the stomach) of adult patients. Clearing Stem Model NG-1036 is indicated for use in nasogastric tubes that are of size 10 - 14 French and have a length of 36 -42 inches (91 - 108 cm). Clearing Stem Model NG-1043 is indicated for use in nasogastric tubes that are of size 10 - 18 French and have a length of 43 - 50 inches (109 - 127 cm).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123659 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123659: Tube-Clear, Control Box (Component of Tubeclear), Clearing Stem (Component of Tubeclear).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123659
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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