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 Dec 4, 2020 as substantially equivalent to K163092 (Actuated Medical, Inc., 2016) after a 267-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Dec 4, 2020
- Review
- 267 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
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 deviceK200646 TubeClear SystemActuated Medical, Inc. · 2020
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) | K200646 | TubeClear System | Actuated Medical, Inc. | 2020 | — |
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 |
|---|---|---|---|
| * | K163092 | TubeClear Control Box and Clearing StemSummary page 5…marketed device to which substantial equivalence is being claimed is as follows: 510(k) Number Trade Name Manufacturer K163092 TubeClear System Actuated Medical, Inc. Device Description The TubeClear System is comprised of a r… | 2016 |
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 29 years and passes through 2 companies; a new generation was cleared every 3.3 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. 2020, 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 GJ-1422 is indicated for use ONLY and SOLELY in clearing occlusions/clogs in adults that have the following Tube type and size (French and length).
+ GJ-1422, for G-Jet®, MIC®, and MIC-KEY® Gastro-jejunostomy tubes that are size 14-22 Fr and have a jejunal length of 15-45 cm (6-18 in).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200646: 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/K200646
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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