510(k) · Cleared
ClearedNavina Smart System, Navina Classic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Sirona · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Nov 22, 2019 as substantially equivalent to K170487 (Dentsply Sirona, 2017) and 1 other predicate after a 221-day review. Its family tree reaches back 8 generations to 1982.
- Decided
- Nov 22, 2019
- Review
- 221 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K813526 (1982). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK813526 Fecal Sanitary TubeLeon'S Fecal Sanitary Tub Mfg. · 1982
- 7 generations backK012113 Indwelling Fecal Management SystemBowel Management Systems, LLC · 2002
- 6 generations backK023344 Indwelling Fecal Management System-Non-SterileBowel Management Systems, LLC · 2002
- 5 generations backK083770 Coloplast Peristeen Anal Irrigation (Pai) SystemColoplast A/S · 2009
- 4 generations backK103254 Peristeen Anal Irrigation System, Irrigation Accessory Unit…Coloplast A/S · 2011
- 3 generations backK112860 Peristeen Anal Irrigation System, Peristeen Anal Irrigation…Coloplast A/S · 2012
- 2 generations backK140310 Peristeen Anal Irrigation SystemColoplast A/S · 2015
- 1 generation backK170487 Navina Classic SystemDentsply Sirona · 2017
- This deviceK190977 Navina Smart System, Navina Classic SystemDentsply Sirona · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K813526 | Fecal Sanitary Tube | Leon'S Fecal Sanitary Tub Mfg. | 1982 | — |
| −7 | K012113 | Indwelling Fecal Management System | Bowel Management Systems, LLC | 2002 | — |
| −6 | K023344 | Indwelling Fecal Management System-Non-Sterile | Bowel Management Systems, LLC | 2002 | — |
| −5 | K083770 | Coloplast Peristeen Anal Irrigation (Pai) System | Coloplast A/S | 2009 | — |
| −4 | K103254 | Peristeen Anal Irrigation System, Irrigation Accessory Unit, Irrigation Rectal… | Coloplast A/S | 2011 | — |
| −3 | K112860 | Peristeen Anal Irrigation System, Peristeen Anal Irrigation Accessory Unit… | Coloplast A/S | 2012 | — |
| −2 | K140310 | Peristeen Anal Irrigation System | Coloplast A/S | 2015 | — |
| −1 | K170487 | Navina Classic System | Dentsply Sirona | 2017 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K170487 | Navina Classic SystemSummary page 4…a Kit] 3. Predicate Devices: Predicate Device Name 510(k) Company Name Navina Classic System K170487 Dentsply Sirona Peristeen Anal Irrigation System K140310 Coloplast A/S 4. Descriptio… | 2017 |
| * | K140310 | Peristeen Anal Irrigation SystemSummary page 4…0(k) Company Name Navina Classic System K170487 Dentsply Sirona Peristeen Anal Irrigation System K140310 Coloplast A/S 4. Description of Device: The purpose of this bundled 510(k) premarket notification is for the… | 2015 |
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 37 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Navina Systems are indicated for use for children (2 - <12 years old), adolescents (12 - <18 years old), and transitional adolescents (18 - <21 years old) patients with neurogenic bowel dysfunction, congenital disorders such as Hirschsprung disease or anorectal malformations, fecal incontinence or chronic constipation where less invasive therapies are not successful, as well as, for adults who suffer from fecal incontinence, chronic constipation…
Read the full statement (189 words)
The Navina Systems are indicated for use for children (2 - <12 years old), adolescents (12 - <18 years old), and transitional adolescents (18 - <21 years old) patients with neurogenic bowel dysfunction, congenital disorders such as Hirschsprung disease or anorectal malformations, fecal incontinence or chronic constipation where less invasive therapies are not successful, as well as, for adults who suffer from fecal incontinence, chronic constipation, and/or time consuming bowel management. Use for pediatric patients is to be performed under the supervision of a trained healthcare professional or adult caregiver. By instilling water up into the lower part of the colon, the Navina Systems promote evacuation of the contents of the colon and rectum.
The Navina Small Rectal Balloon catheter is limited to use for adolescent (12 - <18 years old) and transitional adolescent (18 - < 21 years old) patients and adults. The Navina Regular Rectal Balloon catheter is limited to use for adults. The Navina Cone catheter is limited to use for children (2 - < 12 years old), adolescent (12 - <18 years old) and transitional adolescent (18 - < 21 years old) patients and adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190977 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190977: Navina Smart System, Navina Classic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190977
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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