510(k) · Cleared
ClearedFlexi-Seal AIR (with ENFit Connector)
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 28, 2025 as substantially equivalent to K190114 (Convatec Limited, 2019) after a 171-day review. Its family tree reaches back 7 generations to 1982.
- Decided
- Mar 28, 2025
- Review
- 171 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K813526 (1982). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK813526 Fecal Sanitary TubeLeon'S Fecal Sanitary Tub Mfg. · 1982
- 6 generations backK012113 Indwelling Fecal Management SystemBowel Management Systems, LLC · 2002
- 5 generations backK032734 Convatec Fecal Management SystemConvatec, A Bristol-Myers Squibb Co. · 2004 · Recalled
- 4 generations backK112342 Flexi-Seal Signal Fecal Management SystemConvatec, Inc. · 2012
- 3 generations backK150350 Flexi-Seal Signal Fecal Management SystemConvatec, Ltd. · 2015
- 2 generations backK162906 Flexi-Seal PROTECT Fecal Management SystemConvatec · 2017
- 1 generation backK190114 Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)Convatec Limited · 2019
- This deviceK243228 Flexi-Seal AIR (with ENFit Connector)Convatec · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K813526 | Fecal Sanitary Tube | Leon'S Fecal Sanitary Tub Mfg. | 1982 | — |
| −6 | K012113 | Indwelling Fecal Management System | Bowel Management Systems, LLC | 2002 | — |
| −5 | K032734 | Convatec Fecal Management System | Convatec, A Bristol-Myers Squibb Co. | 2004 | 3 |
| −4 | K112342 | Flexi-Seal Signal Fecal Management System | Convatec, Inc. | 2012 | — |
| −3 | K150350 | Flexi-Seal Signal Fecal Management System | Convatec, Ltd. | 2015 | — |
| −2 | K162906 | Flexi-Seal PROTECT Fecal Management System | Convatec | 2017 | — |
| −1 | K190114 | Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) | Convatec Limited | 2019 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K190114 | Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)Summary page 5…Seal AirTM versus the primary predicate device, Flexi-Seal® PROTECT Plus Fecal Management System ref K190114. (1) A new foam filled retention balloon which is similar to the… | 2019 |
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 43 years and passes through 7 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 8 ancestors has a recall of any class.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Flexi-Seal AIR™ (with ENFit™ Connector) is an indwelling fecal management catheter intended to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications. The device is intended for use in adult 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/K243228 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243228: Flexi-Seal AIR (with ENFit Connector).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243228
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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