510(k) · Cleared
ClearedIncare Advance; Intermittent Catheter, Plus Intermittent Catheter, Plus Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hollister, Inc. · KOD Catheter, Urological
Cleared on Jan 14, 2002 as substantially equivalent to K003784 (Mentor Corp., 2001) and 3 other predicates after an 87-day review. Its family tree reaches back 1 generation to 1998. 20 later devices descend from it.
- Decided
- Jan 14, 2002
- Review
- 87 days
- Class
- Class II
- Product code
- KOD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K973120 (1998). 4 ancestors in all. 20 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK973120 Readycath CatheterMedical Technologies of Georgia · 1998
- This deviceK013483 Incare Advance; Intermittent Catheter, Plus Intermittent Catheter…Hollister, Inc. · 2002
- Descendant · cites it directly · 15 of its ownK090960 Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142…Hollister, Inc. · 2009
- Descendant · cites it directly · 14 of its ownK110862 Vapro Plus Intermittent CatheterHollister Incorporated · 2011
- Descendant · 2 generations on · 13 of its ownK141642 Vapro Intermittent CatheterHollister Incorporated · 2014
- Descendant · 3 generations on · 6 of its ownK180824 VaPro 2 Intermittent CatheterHollister Incorporated · 2018
- Descendant · 4 generations on · 3 of its ownK220667 Sleeved ICHollister Incorporated · 2022
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K090960Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084…Hollister, Inc. · 2009 · cites it directly15descendants
- K110862Vapro Plus Intermittent CatheterHollister Incorporated · 2011 · cites it directly14descendants
- K141642Vapro Intermittent CatheterHollister Incorporated · 2014 · 2 generations on13descendants
- K180824VaPro 2 Intermittent CatheterHollister Incorporated · 2018 · 3 generations on6descendants
- K220667Sleeved ICHollister Incorporated · 2022 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973120 | Readycath Catheter | Medical Technologies of Georgia | 1998 | — |
| 0 (this device) | K013483 | Incare Advance; Intermittent Catheter, Plus Intermittent Catheter, Plus Kit | Hollister, Inc. | 2002 | — |
| +1 | K090960 | Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064… | Hollister, Inc. | 2009 | — |
| +1 | K110862 | Vapro Plus Intermittent Catheter | Hollister Incorporated | 2011 | — |
| +2 | K141642 | Vapro Intermittent Catheter | Hollister Incorporated | 2014 | — |
| +3 | K180824 | VaPro 2 Intermittent Catheter | Hollister Incorporated | 2018 | — |
| +4 | K220667 | Sleeved IC | Hollister Incorporated | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2022 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 KOD? 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 KOD device
- #1 K251864 Rubber Utility Catheterscore 10.9 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K003784 | Mentor Self-Cath PlusSummary page 1…860 Date Summary Prepared — October 17, 2001 2. Name of Device: InCare Pre lubricated Intermittent Catheters 3. Name of Predicate Device(s) Self-Cath Plus by Mentor ~ K003784 InstantCath by MTG K973120 MMG/O’Neil by Rusch K010420 Self Cath CS by Mentor K003873 4. Description of Device The InCare Advan… | 2001 |
| * | K973120 | Readycath CatheterSummary page 1…— October 17, 2001 2. Name of Device: InCare Pre lubricated Intermittent Catheters 3. Name of Predicate Device(s) Self-Cath Plus by Mentor ~ K003784 InstantCath by MTG K973120 MMG/O’Neil by Rusch K010420 Self Cath CS by Mentor K003873 4. Description of Device The InCare Advance and Advance Plus Intermi… | 1998 |
| * | K010420 | Rusch MMG/O'neil CatheterSummary page 1…of Device: InCare Pre lubricated Intermittent Catheters 3. Name of Predicate Device(s) Self-Cath Plus by Mentor ~ K003784 InstantCath by MTG K973120 MMG/O’Neil by Rusch K010420 Self Cath CS by Mentor K003873 4. Description of Device The InCare Advance and Advance Plus Intermittent Catheters are pre-lubr… | 2001 |
| * | K003873 | Mentor Self-Cath Closed SystemSummary page 1…d Intermittent Catheters 3. Name of Predicate Device(s) Self-Cath Plus by Mentor ~ K003784 InstantCath by MTG K973120 MMG/O’Neil by Rusch K010420 Self Cath CS by Mentor K003873 4. Description of Device The InCare Advance and Advance Plus Intermittent Catheters are pre-lubricated with gel to promote easy… | 2001 |
What descends from it? (20)
See all 204 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090960 | Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084… | 2009 | 15 |
| K110862 | Vapro Plus Intermittent Catheter | 2011 | 14 |
| K032710 | Closed System Intermittent Catheterization Kit | 2004 | 2 |
| K033477 | Hydrophilic-Antibacterial Intermittent Catheter, Intermittent Catheter Closed System Kit | 2004 | 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?
How does its category compare?
All KOD devicesKOD Catheter, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KOD
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · KOD
251in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KOD
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KOD
1,389in 2025
MAUDE reports naming product code KOD, 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 | 0 | — | 0 | 180 |
| 2008 | 2 | — | 0 | 102 |
| 2009 | 1 | — | 15 | 183 |
| 2010 | 1 | — | 1 | 228 |
| 2011 | 2 | — | 47 | 209 |
| 2012 | 0 | — | 2 | 165 |
| 2013 | 0 | — | 0 | 393 |
| 2014 | 1 | — | 0 | 226 |
| 2015 | 0 | — | 0 | 418 |
| 2016 | 2 | — | 1 | 284 |
| 2017 | 1 | — | 0 | 1,873 |
| 2018 | 6 | 251 | 0 | 1,179 |
| 2019 | 1 | — | 1 | 1,167 |
| 2020 | 0 | — | 0 | 1,370 |
| 2021 | 1 | — | 0 | 1,388 |
| 2022 | 2 | — | 3 | 1,280 |
| 2023 | 0 | — | 1 (1) | 1,160 |
| 2024 | 0 | — | 0 | 1,259 |
| 2025 | 0 | — | 0 | 1,389 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The InCare Pre-lubricated Intermittent Catheter is indicated for use by male, female and pediatric patients for the purpose of bladder drainage. The Catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract.
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/K013483 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013483: Incare Advance; Intermittent Catheter, Plus Intermittent Catheter, Plus Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013483
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026