510(k) · Cleared
ClearedQora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Consure Medical Pvt, Ltd. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on May 6, 2016 as substantially equivalent to K133465 (Consure Medical Pvt, Ltd., 2014) after a 151-day review. Its family tree reaches back 6 generations to 1982. 1 later device descends from it.
- Decided
- May 6, 2016
- Review
- 151 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K813526 (1982). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK813526 Fecal Sanitary TubeLeon'S Fecal Sanitary Tub Mfg. · 1982
- 5 generations backK012113 Indwelling Fecal Management SystemBowel Management Systems, LLC · 2002
- 4 generations backK023344 Indwelling Fecal Management System-Non-SterileBowel Management Systems, LLC · 2002
- 3 generations backK073598 Bard Dignicare Stool Management SystemC.R. Bard, Inc. · 2008
- 2 generations backK102391 Bard Dignishield Stool Management SystemC.R. Bard, Inc. · 2010
- 1 generation backK133465 Consure Stool Management SystemConsure Medical Pvt, Ltd. · 2014
- This deviceK153506 Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora…Consure Medical Pvt, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK212444 Qora Stool Management KitCm Technologies, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K212444Qora Stool Management KitCm Technologies, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K813526 | Fecal Sanitary Tube | Leon'S Fecal Sanitary Tub Mfg. | 1982 | — |
| −5 | K012113 | Indwelling Fecal Management System | Bowel Management Systems, LLC | 2002 | — |
| −4 | K023344 | Indwelling Fecal Management System-Non-Sterile | Bowel Management Systems, LLC | 2002 | — |
| −3 | K073598 | Bard Dignicare Stool Management System | C.R. Bard, Inc. | 2008 | — |
| −2 | K102391 | Bard Dignishield Stool Management System | C.R. Bard, Inc. | 2010 | — |
| −1 | K133465 | Consure Stool Management System | Consure Medical Pvt, Ltd. | 2014 | — |
| 0 (this device) | K153506 | Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida… | Consure Medical Pvt, Ltd. | 2016 | — |
| +1 | K212444 | Qora Stool Management Kit | Cm Technologies, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K133465 | Consure Stool Management SystemSummary page 4…K153506 Document Traditional 510(k) Submission Title Premarket Notification [510(k)] for K133465 Line Extensions Date May 4, 2016 Page 1 of 4… | 2014 |
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 |
|---|---|---|---|
| K212444 | Qora Stool Management Kit | 2021 | 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 34 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K212444 (Cm Technologies, Inc., 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Qora AIM™ Stool Management Kit is indicated for fecal management by diverting and collecting liquid or semi-formed stool to minimize skin contact in bedridden patients. The device is for use in patients 18 years and older only. The uninterrupted use for this device, including replacement with other same devices, should not exceed 29 days. The Qora Aeon™ Stool Management Kit is indicated for fecal management by diverting and collecting liquid or…
Read the full statement (187 words)
The Qora AIM™ Stool Management Kit is indicated for fecal management by diverting and collecting liquid or semi-formed stool to minimize skin contact in bedridden patients. The device is for use in patients 18 years and older only. The uninterrupted use for this device, including replacement with other same devices, should not exceed 29 days.
The Qora Aeon™ Stool Management Kit is indicated for fecal management by diverting and collecting liquid or semi-formed stool to minimize skin contact in bedridden patients. The device is for use in patients 18 years and older only. The uninterrupted use for this device, including replacement with other same devices, should not exceed 29 days.
The Qora Arida™ Stool Management Kit is indicated for fecal management by diverting and collecting liquid or semi-formed stool to minimize skin contact in bedridden patients. The device is for use in patients 18 years and older only. The uninterrupted use for this device is intended to be until the collection pouch is filled or until it has been utilized for 72 hours, whichever comes first. The replacement with other same devices should not exceed 29 days.
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/K153506 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153506: Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153506
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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