510(k) · Cleared
ClearedColoplast Peristeen Anal Irrigation (Pai) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast A/S · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Nov 23, 2009 as substantially equivalent to K023344 (Bowel Management Systems, LLC, 2002) after a 340-day review. Its family tree reaches back 3 generations to 1982. 5 later devices descend from it.
- Decided
- Nov 23, 2009
- Review
- 340 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K813526 (1982). 4 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK813526 Fecal Sanitary TubeLeon'S Fecal Sanitary Tub Mfg. · 1982
- 2 generations backK012113 Indwelling Fecal Management SystemBowel Management Systems, LLC · 2002
- 1 generation backK023344 Indwelling Fecal Management System-Non-SterileBowel Management Systems, LLC · 2002
- This deviceK083770 Coloplast Peristeen Anal Irrigation (Pai) SystemColoplast A/S · 2009
- Descendant · cites it directly · 4 of its ownK103254 Peristeen Anal Irrigation System, Irrigation Accessory Unit…Coloplast A/S · 2011
- Descendant · cites it directly · 3 of its ownK112860 Peristeen Anal Irrigation System, Peristeen Anal Irrigation…Coloplast A/S · 2012
- Descendant · 2 generations on · 2 of its ownK140310 Peristeen Anal Irrigation SystemColoplast A/S · 2015
- Descendant · 3 generations on · 1 of its ownK170487 Navina Classic SystemDentsply Sirona · 2017
- Descendant · 3 generations on · 0 of its ownK190977 Navina Smart System, Navina Classic SystemDentsply Sirona · 2019
Most influential descendants
Showing 5 of 5 · See all- K103254Peristeen Anal Irrigation System, Irrigation Accessory Unit, Irrigation Rectal Catheter…Coloplast A/S · 2011 · cites it directly4descendants
- K112860Peristeen Anal Irrigation System, Peristeen Anal Irrigation Accessory Unit, Peristeen…Coloplast A/S · 2012 · cites it directly3descendants
- K140310Peristeen Anal Irrigation SystemColoplast A/S · 2015 · 2 generations on2descendants
- K170487Navina Classic SystemDentsply Sirona · 2017 · 3 generations on1descendant
- K190977Navina Smart System, Navina Classic SystemDentsply Sirona · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K813526 | Fecal Sanitary Tube | Leon'S Fecal Sanitary Tub Mfg. | 1982 | — |
| −2 | K012113 | Indwelling Fecal Management System | Bowel Management Systems, LLC | 2002 | — |
| −1 | K023344 | Indwelling Fecal Management System-Non-Sterile | Bowel Management Systems, LLC | 2002 | — |
| 0 (this device) | K083770 | Coloplast Peristeen Anal Irrigation (Pai) System | Coloplast A/S | 2009 | — |
| +1 | K103254 | Peristeen Anal Irrigation System, Irrigation Accessory Unit, Irrigation Rectal… | Coloplast A/S | 2011 | — |
| +1 | K112860 | Peristeen Anal Irrigation System, Peristeen Anal Irrigation Accessory Unit… | Coloplast A/S | 2012 | — |
| +2 | K140310 | Peristeen Anal Irrigation System | Coloplast A/S | 2015 | — |
| +3 | K170487 | Navina Classic System | Dentsply Sirona | 2017 | — |
| +3 | K190977 | Navina Smart System, Navina Classic System | Dentsply Sirona | 2019 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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? (2)
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 |
|---|---|---|---|
| * | K023344 | Indwelling Fecal Management System-Non-SterileSummary page 1…in performance, indications, design and materials to Zassi Medical Bowel Management System (BMS), cleared on November 6, 2002 under premarket notification 510(k) number K023344, and the Aresure Enema Cleansing Bag, a Class I (Exempt) Enema Kit per 21 CFR section 876.5210.… | 2002 |
| * | — | Aresure Enema Cleansing Bag Named without a submission number |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 27 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K103254 (Coloplast A/S, 2011) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K023344.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Peristeen Anal Irrigation (PAI) System is intended to instill water into the colon through a rectal catheter - which incorporates an inflatable balloon - inserted into the rectum to promote evacuation of the contents of the lower colon. The PAI System is indicated for use by adolescent (12 years - < 18 years old), transitional adolescent (18 - < 21 years old) and adult spinal cord injury patients with neurogenic bowel dysfunction who suffer from fecal incontinence, chronic constipation, and/or time-consuming bowel management procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083770 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083770: Coloplast Peristeen Anal Irrigation (Pai) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083770
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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