510(k) · Cleared
Cleared20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tangent Medical Technologies, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Mar 11, 2016 as substantially equivalent to K120839 (Tangent Medical Technologies, Inc., 2012) after a 30-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Mar 11, 2016
- Review
- 30 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K971339 (1997). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK971339 Insyte, Insyte-W, Insyte Autoguard CathetersBecton Dickinson Vascular Access, Inc. · 1997
- 1 generation backK120839 Novacath Secure IV Catheter System-18GTangent Medical Technologies, Inc. · 2012
- This deviceK160374 20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath…Tangent Medical Technologies, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971339 | Insyte, Insyte-W, Insyte Autoguard Catheters | Becton Dickinson Vascular Access, Inc. | 1997 | — |
| −1 | K120839 | Novacath Secure IV Catheter System-18G | Tangent Medical Technologies, Inc. | 2012 | — |
| 0 (this device) | K160374 | 20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV… | Tangent Medical Technologies, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 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 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? (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 |
|---|---|---|---|
| * | K120839 | Novacath Secure IV Catheter System-18GSummary page 4…assification Intravascular Catheter Name: Classification FOZ Code: Regulation 21 CFR §880.5200 Number: Predicate NovaCath™ Secure IV Catheter System (K120839) Device: Device The NovaCath™ Secure IV Catheter System is a short-term, therapeutic, IV catheter. The Description:… | 2012 |
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 19 years and passes through 2 companies; a new generation was cleared every 14.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
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. 2016, 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?
The NovaCath™ Secure IV Catheter System is inserted into the patient’s vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The needle-shielding feature aids in the prevention of needlestick injuries. Upon catheter insertion, blood is contained within the device to aid in the prevention of blood exposure. The NovaCath™ device may be utilized in any patient population with consideration given to vascular anatomy and appropriateness of procedure. The 18, 20, and 22 gauge NovaCath™ devices are suitable for use with power injectors for a maximum of 300psi.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160374 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160374: 20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160374
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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