510(k) · Cleared
Clearedhygh-tec drainage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Creative Balloons GmbH · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Feb 9, 2023 as substantially equivalent to K150350 (Convatec, Ltd., 2015) after a 269-day review. Its family tree reaches back 5 generations to 1982. 1 later device descends from it.
- Decided
- Feb 9, 2023
- Review
- 269 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K813526 (1982). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK813526 Fecal Sanitary TubeLeon'S Fecal Sanitary Tub Mfg. · 1982
- 4 generations backK012113 Indwelling Fecal Management SystemBowel Management Systems, LLC · 2002
- 3 generations backK032734 Convatec Fecal Management SystemConvatec, A Bristol-Myers Squibb Co. · 2004 · Recalled
- 2 generations backK112342 Flexi-Seal Signal Fecal Management SystemConvatec, Inc. · 2012
- 1 generation backK150350 Flexi-Seal Signal Fecal Management SystemConvatec, Ltd. · 2015
- This deviceK221400 hygh-tec drainageCreative Balloons GmbH · 2023
- Descendant · cites it directly · 0 of its ownK242336 hygh-tec Drainage IIAmb Medtec · 2025
Most influential descendants
Showing 1 of 1 · See all- K242336hygh-tec Drainage IIAmb Medtec · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K813526 | Fecal Sanitary Tube | Leon'S Fecal Sanitary Tub Mfg. | 1982 | — |
| −4 | K012113 | Indwelling Fecal Management System | Bowel Management Systems, LLC | 2002 | — |
| −3 | K032734 | Convatec Fecal Management System | Convatec, A Bristol-Myers Squibb Co. | 2004 | 3 |
| −2 | K112342 | Flexi-Seal Signal Fecal Management System | Convatec, Inc. | 2012 | — |
| −1 | K150350 | Flexi-Seal Signal Fecal Management System | Convatec, Ltd. | 2015 | — |
| 0 (this device) | K221400 | hygh-tec drainage | Creative Balloons GmbH | 2023 | — |
| +1 | K242336 | hygh-tec Drainage II | Amb Medtec | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K150350 | Flexi-Seal Signal Fecal Management SystemSummary page 4…Tubes, Gastrointestinal (And Accessories) III. PREDICATE DEVICE Primary Predicate Flexi-Seal® SIGNALTM Fecal Management System, K150350 K221400 Page 2 of 6 IV. DE… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242336 | hygh-tec Drainage II | 2025 | 0 |
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 41 years and passes through 6 companies; a new generation was cleared every 7.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K242336 (Amb Medtec, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K150350.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
The hygh-tec drainage is a fecal management system that is intended for continuous, trans-anal drainage and collection of liquid or semi-liquid stools and to provide access for the administration of medications. The device is not intended for use on pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221400 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221400: hygh-tec drainage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221400
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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