510(k) · Cleared
ClearedTubeclear
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 13, 2012 as substantially equivalent to K905164 (Nova Design Technologies, Ltd., 1991) after a 15-day review. Its family tree reaches back 1 generation to 1991. 6 later devices descend from it.
- Decided
- Jun 13, 2012
- Review
- 15 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K905164 (1991). 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK905164 Tube DecloggerNova Design Technologies, Ltd. · 1991
- This deviceK121571 TubeclearActuated Medical, Inc. · 2012
- Descendant · cites it directly · 4 of its ownK123659 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 · cites it directly · 0 of its ownK180605 GastroFlushBionix Development Corporation · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K123659Tube-Clear, Control Box (Component of Tubeclear), Clearing Stem (Component of Tubeclear)Actuated Medical, Inc. · 2012 · cites it directly4descendants
- 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
- K180605GastroFlushBionix Development Corporation · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905164 | Tube Declogger | Nova Design Technologies, Ltd. | 1991 | — |
| 0 (this device) | K121571 | Tubeclear | Actuated Medical, Inc. | 2012 | — |
| +1 | 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 | — |
| +1 | K180605 | GastroFlush | Bionix Development Corporation | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 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 |
|---|---|---|---|
| * | K905164 | Tube DecloggerSummary page 1…21 C.F.R. §876.5980 5.3: Predicate Device The DeClogger, manufactured by Nova Design Technologies and cleared under 51 0(k) K905164 is the predicate device. 5-1… | 1991 |
What descends from it? (6)
3 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?
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 TM 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/K121571 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121571: Tubeclear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121571
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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