510(k) · Cleared
ClearedAll Silicone Supra-Pubia Catheter, Models 4880/4890
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fortune Medical Instrument Corp. · KOB Catheter, Suprapubic (And Accessories)
Cleared on Mar 4, 2002 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Mar 4, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- KOB
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK014002 All Silicone Supra-Pubia Catheter, Models 4880/4890Fortune Medical Instrument Corp. · 2002
- Descendant · cites it directly · 1 of its ownK181097 Cook Cystostomy Catheter SetCook Incorporated · 2019
- Descendant · cites it directly · 1 of its ownK132890 Suprapubic Catheter and Introducer SetMediplus, Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK240514 AMT Low-Profile Suprapubic Catheter & Drainage SetApplied Medical Technology, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK182066 O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetCook Incorporated · 2018
Most influential descendants
Showing 4 of 4 · See all- K181097Cook Cystostomy Catheter SetCook Incorporated · 2019 · cites it directly1descendant
- K132890Suprapubic Catheter and Introducer SetMediplus, Ltd. · 2014 · cites it directly1descendant
- K240514AMT Low-Profile Suprapubic Catheter & Drainage SetApplied Medical Technology, Inc. · 2024 · 2 generations on0descendants
- K182066O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetCook Incorporated · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K014002 | All Silicone Supra-Pubia Catheter, Models 4880/4890 | Fortune Medical Instrument Corp. | 2002 | — |
| +1 | K181097 | Cook Cystostomy Catheter Set | Cook Incorporated | 2019 | — |
| +1 | K132890 | Suprapubic Catheter and Introducer Set | Mediplus, Ltd. | 2014 | — |
| +2 | K240514 | AMT Low-Profile Suprapubic Catheter & Drainage Set | Applied Medical Technology, Inc. | 2024 | — |
| +2 | K182066 | O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set | Cook Incorporated | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 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 KOB? 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 KOB device
- #1 K240514 AMT Low-Profile Suprapubic Catheter & Drainage…score 8.9 · 3 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
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?
- Of its descendants, K181097 (Cook Incorporated, 2019) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KOB devicesKOB Catheter, Suprapubic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KOB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KOB
Too few KOB 510(k)s in any year since 2007 to give a median.
Recalls per year · KOB
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KOB
1in 2025
MAUDE reports naming product code KOB, 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 | 2 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 12 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 2 | — | 0 | 18 |
| 2019 | 1 | — | 2 | 4 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Suprapubic Catheter is intended to use for drainage of the bladder through a needle puncture or stab wound over 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/K014002 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014002: All Silicone Supra-Pubia Catheter, Models 4880/4890.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014002
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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