510(k) · Cleared
ClearedFlexi-Seal PROTECT Fecal Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Convatec · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Mar 7, 2017 as substantially equivalent to K150350 (Convatec, Ltd., 2015) after a 141-day review. Its family tree reaches back 5 generations to 1982. 2 later devices descend from it.
- Decided
- Mar 7, 2017
- Review
- 141 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. 2 later devices descend 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 deviceK162906 Flexi-Seal PROTECT Fecal Management SystemConvatec · 2017
- Descendant · cites it directly · 1 of its ownK190114 Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)Convatec Limited · 2019
- Descendant · 2 generations on · 0 of its ownK243228 Flexi-Seal AIR (with ENFit Connector)Convatec · 2025
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 |
|---|---|---|---|---|---|
| −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) | K162906 | Flexi-Seal PROTECT Fecal Management System | Convatec | 2017 | — |
| +1 | K190114 | Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) | Convatec Limited | 2019 | — |
| +2 | K243228 | Flexi-Seal AIR (with ENFit Connector) | Convatec | 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 |
|---|---|---|
| 2019 | 1 | 0 |
| 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…Panel: Gastroenterology and Urology Classification Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Predicate Devices: 510(K) number: K150350 Flexi-Seal® SIGNAL™ Fecal Management System… | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190114 | Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) | 2019 | 1 |
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 35 years and passes through 6 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K190114 (Convatec Limited, 2019) has gone furthest, with 1 descendant 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. 2017, 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 Flexi-Seal® PROTECT ™ Fecal Management System is an indwelling fecal management catheter intended for use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications. The device is not intended for use on pediatric patients.
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/K162906 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162906: Flexi-Seal PROTECT Fecal Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162906
Report an extraction error
Are you the manufacturer?
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