510(k) · Cleared
ClearedTubeClear Control Box and Clearing Stem
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 Nov 30, 2016 as substantially equivalent to K131052 (Actuated Medical, Inc., 2013) after a 26-day review. Its family tree reaches back 4 generations to 1991. 2 later devices descend from it.
- Decided
- Nov 30, 2016
- Review
- 26 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K905164 (1991). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK905164 Tube DecloggerNova Design Technologies, Ltd. · 1991
- 3 generations backK121571 TubeclearActuated Medical, Inc. · 2012
- 2 generations backK123659 Tube-Clear, Control Box (Component of Tubeclear), Clearing Stem…Actuated Medical, Inc. · 2012
- 1 generation backK131052 Tubeclear Model 101 (with New Clearing Stem NE and G Models)Actuated Medical, Inc. · 2013
- This deviceK163092 TubeClear Control Box and Clearing StemActuated Medical, Inc. · 2016
- Descendant · cites it directly · 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K905164 | Tube Declogger | Nova Design Technologies, Ltd. | 1991 | — |
| −3 | K121571 | Tubeclear | Actuated Medical, Inc. | 2012 | — |
| −2 | 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 | — |
| 0 (this device) | K163092 | TubeClear Control Box and Clearing Stem | Actuated Medical, Inc. | 2016 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K131052 | Tubeclear Model 101 (with New Clearing Stem NE and G Models)Summary page 5…: Predicate Device The legally marketed device to which substantial equivalence is being claimed: 510(k) Number Trade Name Manufacturer K131052 TubeClear Actuated Medical, Inc. The Predicate Device, TubeClear, is comprised of Control Box Model 101 and Cle… | 2013 |
What descends from it? (2)
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 25 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K200646 (Actuated Medical, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K131052.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 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…
Read the full statement (226 words)
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).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163092 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163092: TubeClear Control Box and Clearing Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163092
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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