510(k) · Cleared
ClearedClosed System Intermittent Catheterization Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apogee Medical, Inc. · KOD Catheter, Urological
Cleared on Jan 9, 2004 as substantially equivalent to K003873 (Mentor Corp., 2001) and 1 other predicate after a 129-day review. Its family tree reaches back 2 generations to 1998. 2 later devices descend from it.
- Decided
- Jan 9, 2004
- Review
- 129 days
- Class
- Class II
- Product code
- KOD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K973120 (1998). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK973120 Readycath CatheterMedical Technologies of Georgia · 1998
- 1 generation backK013483 Incare Advance; Intermittent Catheter, Plus Intermittent Catheter…Hollister, Inc. · 2002
- This deviceK032710 Closed System Intermittent Catheterization KitApogee Medical, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK160877 United Urologics Closed System CatheterRobling Medical, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK080878 MTG Instant Cather (with and Without Kit), MTG Instant Cath Deluxe…Medical Technologies of Georgia, Inc. · 2008
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 | K973120 | Readycath Catheter | Medical Technologies of Georgia | 1998 | — |
| −1 | K013483 | Incare Advance; Intermittent Catheter, Plus Intermittent Catheter, Plus Kit | Hollister, Inc. | 2002 | — |
| 0 (this device) | K032710 | Closed System Intermittent Catheterization Kit | Apogee Medical, Inc. | 2004 | — |
| +1 | K160877 | United Urologics Closed System Catheter | Robling Medical, Inc. | 2016 | — |
| +1 | K080878 | MTG Instant Cather (with and Without Kit), MTG Instant Cath Deluxe (with and… | Medical Technologies of Georgia, Inc. | 2008 | — |
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 |
|---|---|---|
| 2008 | 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 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? (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 |
|---|---|---|---|
| * | K003873 | Mentor Self-Cath Closed SystemSummary page 1…e Medical, Inc. 90 Weathers Street Youngsville, NC 27596 Name of Predicate Device(s): Mentor Self-Cath Closed System K003873 Hollister InCare Pre-Lubricated Intermittent Catheters K013483 Device Description: The Apogee Closed System Intermit… | 2001 |
| * | K013483 | Incare Advance; Intermittent Catheter, Plus Intermittent Catheter, Plus KitSummary page 1…Name of Predicate Device(s): Mentor Self-Cath Closed System K003873 Hollister InCare Pre-Lubricated Intermittent Catheters K013483 Device Description: The Apogee Closed System Intermittent Catheterization Kit is a single-use, disposable, pre-lubricated cathe… | 2002 |
What descends from it? (2)
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 6 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K160877 (Robling Medical, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K003873.
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 Apogee Closed System Intermittent Catheterization Kit is intended to be used to drain urine from the patient's bladder into a collection bag.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032710 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032710: Closed System Intermittent Catheterization Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032710
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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