510(k) · Decided
DecidedIcath, Sterilesure
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Colorado Catheter Company, Inc. · NWO Kit, Catheter, Urinary (Exludes Hiv Testing)
Cleared on Aug 15, 2007 as substantially equivalent to K052440 (Mentor Corporation, 2005) after a 76-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it.
- Decided
- Aug 15, 2007
- Review
- 76 days
- Class
- Class II
- Product code
- NWO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003874 (2001). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK003874 CBC-4K Hematology ControlR&D Systems, Inc. · 2001
- 1 generation backK052440 Mentor Self-Cath Hydrogel Intermittent CatheterMentor Corporation · 2005
- This deviceK071496 Icath, SterilesureColorado Catheter Company, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK103043 Colorado Catheter Sterilesure - New Name Perfic CathAdapta Medical, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK161445 PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC…Adapta Medical, Inc. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003874 | CBC-4K Hematology Control | R&D Systems, Inc. | 2001 | — |
| −1 | K052440 | Mentor Self-Cath Hydrogel Intermittent Catheter | Mentor Corporation | 2005 | — |
| 0 (this device) | K071496 | Icath, Sterilesure | Colorado Catheter Company, Inc. | 2007 | — |
| +1 | K103043 | Colorado Catheter Sterilesure - New Name Perfic Cath | Adapta Medical, Inc. | 2011 | — |
| +2 | K161445 | PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C | Adapta Medical, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2016 | 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 NWO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K052440 | Mentor Self-Cath Hydrogel Intermittent CatheterSummary page 2…ntially equivalent in form and function to Mentor Self-Cath® HydroGeflT Intermittent Urethral Urinary Catheter, which was cleared under 510(k) number K052440. Indications for Use The Colorado Catheter iCathTh and SterileSureTM are intended for use in adult male and… | 2005 |
| † | K871999 | MMG Uro-Self Catheter | 1987 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103043 | Colorado Catheter Sterilesure - New Name Perfic Cath | 2011 | 1 |
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 6 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K103043 (Adapta Medical, Inc., 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NWO devicesNWO Kit, Catheter, Urinary (Exludes Hiv Testing): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NWO
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · NWO
Too few NWO 510(k)s in any year since 2007 to give a median.
Recalls per year · NWO
1in 2014
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NWO
1in 2023
MAUDE reports naming product code NWO, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 1 (1) | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Colorado Catheter iCathTM and SterileSure TM are intended for use in adult male and adult female patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071496 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071496: Icath, Sterilesure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071496
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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