510(k) · Cleared
Recalled · 2008Urological Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apogee, Inc. · GBM Catheter, Urethral
Cleared on Sep 3, 1999 after a 71-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it. It has been recalled 5 times.
- Decided
- Sep 3, 1999
- Review
- 71 days
- Class
- Class II
- Product code
- GBM
- Recalls
- 5
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK992137 Urological CatheterApogee, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK160795 United Urologics Intermittent CatheterRobling Medical · 2016
Most influential descendants
Showing 1 of 1 · See all- K160795United Urologics Intermittent CatheterRobling Medical · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992137 | Urological Catheter | Apogee, Inc. | 1999 | — |
| +1 | K160795 | United Urologics Intermittent Catheter | Robling Medical | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GBM? 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 GBM device
- #1 K241734 Wellead® Hydrophilic Intermittent Catheter…score 10.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160795 | United Urologics Intermittent Catheter | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 17, 2008 | Not classified | Z-2390-2008 | Packaging process control | Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised. |
| Jul 17, 2008 | Not classified | Z-2394-2008 | Packaging process control | Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised. |
| Jul 17, 2008 | Not classified | Z-2392-2008 | Packaging process control | Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised. |
| Jul 17, 2008 | Not classified | Z-2391-2008 | Packaging process control | Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised. |
| Jul 17, 2008 | Not classified | Z-2393-2008 | Packaging process control | Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K160795 (Robling Medical, 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GBM devicesGBM Catheter, Urethral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GBM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GBM
230in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GBM
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GBM
311in 2025
MAUDE reports naming product code GBM, 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 | 2 | — | 0 | 5 |
| 2008 | 0 | — | 5 | 18 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 33 |
| 2011 | 2 | — | 1 | 46 |
| 2012 | 3 | 139 | 0 | 32 |
| 2013 | 0 | — | 0 | 41 |
| 2014 | 1 | — | 0 | 19 |
| 2015 | 5 | 76 | 0 | 21 |
| 2016 | 3 | 112 | 0 | 49 |
| 2017 | 2 | — | 0 | 59 |
| 2018 | 6 | 93 | 0 | 82 |
| 2019 | 7 | 121 | 0 | 148 |
| 2020 | 6 | 230 | 0 | 144 |
| 2021 | 0 | — | 0 | 102 |
| 2022 | 2 | — | 0 | 283 |
| 2023 | 0 | — | 1 (1) | 202 |
| 2024 | 0 | — | 0 | 468 |
| 2025 | 1 | — | 1 | 311 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Apogee Medical, Inc. Urinary Catheter is intended to be used as a urinary incontinence device designed to drain urine from the bladder
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992137 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992137: Urological Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992137
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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