510(k) · Cleared
ClearedOne-Step Suprapubic Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · KOB Catheter, Suprapubic (And Accessories)
Cleared on Dec 26, 2018 as substantially equivalent to K884061 (Femcare, Ltd., 1988) after a 90-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Dec 26, 2018
- Review
- 90 days
- Class
- Class II
- Product code
- KOB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K884061 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK884061 Add-a-CathFemcare, Ltd. · 1988
- This deviceK182709 One-Step Suprapubic IntroducerCook Incorporated · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K884061 | Add-a-Cath | Femcare, Ltd. | 1988 | — |
| 0 (this device) | K182709 | One-Step Suprapubic Introducer | Cook Incorporated | 2018 | — |
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 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? (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 |
|---|---|---|---|
| * | K884061 | Add-a-CathSummary page 4…ep Suprapubic Introducer is substantially equivalent to the following device: • Predicate device: Supra-Foley Suprapubic Catheter Introducer cleared under K884061 Device Description: The One-Step Suprapubic Introducer is comprised of a stainless steel trocar stylet needle and a dilator with… | 1988 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All KOB devicesKOB Catheter, Suprapubic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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 One-Step Suprapubic Introducer is used for introducing a drainage catheter suprapubically into the bladder.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182709 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182709: One-Step Suprapubic Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182709
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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