510(k) · Cleared
ClearedAMT Low-Profile Suprapubic Catheter & Drainage Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Technology, Inc. · KOB Catheter, Suprapubic (And Accessories)
Cleared on Nov 1, 2024 as substantially equivalent to K181097 (Cook Incorporated, 2019) after a 253-day review. Its family tree reaches back 3 generations to 1981.
- Decided
- Nov 1, 2024
- Review
- 253 days
- Class
- Class II
- Product code
- KOB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K810368 (1981). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK810368 Vance Percutaneous Malecot NephrostomyVance Products, Inc. · 1981 · Recalled
- 2 generations backK140085 Universa Percultaneous Drainage CatheterCook Incorporated · 2014
- 1 generation backK181097 Cook Cystostomy Catheter SetCook Incorporated · 2019
- This deviceK240514 AMT Low-Profile Suprapubic Catheter & Drainage SetApplied Medical Technology, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K810368 | Vance Percutaneous Malecot Nephrostomy | Vance Products, Inc. | 1981 | 3 |
| −2 | K140085 | Universa Percultaneous Drainage Catheter | Cook Incorporated | 2014 | — |
| −1 | K181097 | Cook Cystostomy Catheter Set | Cook Incorporated | 2019 | — |
| 0 (this device) | K240514 | AMT Low-Profile Suprapubic Catheter & Drainage Set | Applied Medical Technology, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2002 | 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 KOB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K181097 | Cook Cystostomy Catheter SetSummary page 5…egulation Number: 21 CFR 876.5090 Review Panel: Gastroenterology/Urology Regulatory Class: II Product Code: KOB III. PREDICATE/REFERENCE INFORMATION: Predicate Device: K181097 (Cook Cystostomy Catheter Set; Cook Incorporated) Reference Device: K161413 (Low-Profile Balloon Feeding Device; Applied Medical… | 2019 |
| † | K161413 | Low Profile Balloon Feeding Device | 2017 |
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?
- The line of descent spans 43 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All KOB devicesKOB Catheter, Suprapubic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 AMT Low-Profile Suprapubic Catheter & Drainage Set is indicated for patients 7 years of age and older with lower urinary tract dysfunctions such as neurogenic bladder dysfunction, congenital malformation or urethral obstruction, or who are severely disabled or requiring constant care. The AMT Low-Profile Suprapubic Catheter & Drainage Set is indicated to be used for temporary suprapubic urinary diversion and drainage for less than or equal to four weeks. The AMT Low- Profile Suprapubic Catheter is intended to be placed directly into the bladder through a secured (initial placement) or formed (replacement) stoma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240514: AMT Low-Profile Suprapubic Catheter & Drainage Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240514
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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