510(k) · Cleared
ClearedAmecath CVC and Amecath Pressure CVC Short Term Single and Multi-Lumen Catherization Kits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ameco Medical Industries · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Dec 21, 2011 after a 274-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Dec 21, 2011
- Review
- 274 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 FOZ? 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 FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 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?
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.
How does its category compare?
All FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
MAUDE reports naming product code FOZ, 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 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
What is it indicated for?
Indicated to permit short-term (<30 day) central venious access for the treatment of diseases or conditions requiring central venous access, including, but not limited to the following: * Lack of usable peripheral IV sites * Central venious pressure monitoring * Total parenterall nutrition (TPN) * Multiple infusions of fluids, medications, or chemotherapy * Frequent blood sampling or receiving blood transfusions/blood products * Infusions that are…
Read the full statement (119 words)
Indicated to permit short-term (<30 day) central venious access for the treatment of diseases or conditions requiring central venous access, including, but not limited to the following:
* Lack of usable peripheral IV sites
* Central venious pressure monitoring
* Total parenterall nutrition (TPN)
* Multiple infusions of fluids, medications, or chemotherapy
* Frequent blood sampling or receiving blood transfusions/blood products
* Infusions that are hypertonic, hyperosmolar, or infusions that have divergent pH values
in pressure CVC only
* Injection of contrast media
When used for pressure injection of contrast media, do not exceed the maximumn indicated flow rate for each cahtrlmn Th maium pressure of power injector equipment used with the pressure injectable CVC may not exceed 300psi.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K110794 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110794: Amecath CVC and Amecath Pressure CVC Short Term Single and Multi-Lumen Catherization Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110794
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026