510(k) · Cleared
ClearedChait Cecostomy Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Jan 27, 1999 as substantially equivalent to K851242 (Cook, Inc., 1985) after a 191-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it.
- Decided
- Jan 27, 1999
- Review
- 191 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K851242 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK851242 Greco-Harvey Surfactant Bonded Catheter for GastroCook, Inc. · 1985
- This deviceK982500 Chait Cecostomy CatheterCook, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK180026 Bowel Management Device, Bowel Management Irrigation SetApplied Medical Technology, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K180026Bowel Management Device, Bowel Management Irrigation SetApplied Medical Technology, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K851242 | Greco-Harvey Surfactant Bonded Catheter for Gastro | Cook, Inc. | 1985 | — |
| 0 (this device) | K982500 | Chait Cecostomy Catheter | Cook, Inc. | 1999 | — |
| +1 | K180026 | Bowel Management Device, Bowel Management Irrigation Set | Applied Medical Technology, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K851242 | Greco-Harvey Surfactant Bonded Catheter for GastroSummary page 2…anufactured in either Ultrathane™ or polyurethane. These devices are classified as modified Preamendment devices and were also reviewed as substantially equivalent under K851242. The Ultrathane™ Biliary Drainage Catheter is manufactured with a single lumen polyurethane tubing measuring 8.5, 10.2, 12.0, an… | 1985 |
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 |
|---|---|---|---|
| K180026 | Bowel Management Device, Bowel Management Irrigation Set | 2018 | 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?
- Its one ancestor has no recall.
- Of its descendants, K180026 (Applied Medical Technology, Inc., 2018) 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.
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 Chait Cecostomy Catheter is used to instill fluids through a cecostomy into the colon to promote evacuation of the contents of the lower bowel through the anal opening and is intended to be an aid in the management of fecal incontinence. The catheter is placed and maintained in a percutaneously prepared opening such as a cecostomy.
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/K982500 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982500: Chait Cecostomy Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982500
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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