510(k) · Cleared

Cleared

Novacath Secure IV Catheter System-18G

K120839510(k) TraditionalCleared Jul 20, 2012122-day reviewClass II21 CFR 880.5200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Tangent Medical Technologies, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Cleared on Jul 20, 2012 as substantially equivalent to K032843 (Becton Dickinson Infusion Therapy Systems, Inc., 2004) and 2 other predicates after a 122-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.

Decided: Jul 20, 2012
Review: 122 days
Class: Class II
Product code: FOZ
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K971339 (1997). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK971339 Insyte, Insyte-W, Insyte Autoguard CathetersBecton Dickinson Vascular Access, Inc. · 1997
This deviceK120839 Novacath Secure IV Catheter System-18GTangent Medical Technologies, Inc. · 2012
Descendant · cites it directly · 0 of its ownK160374 20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath…Tangent Medical Technologies, Inc. · 2016

Most influential descendants

Showing 1 of 1 · See all

K16037420G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter…Tangent Medical Technologies, Inc. · 2016 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K971339	Insyte, Insyte-W, Insyte Autoguard Catheters	Becton Dickinson Vascular Access, Inc.	1997	—
0 (this device)	K120839	Novacath Secure IV Catheter System-18G	Tangent Medical Technologies, Inc.	2012	—
+1	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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0

FIG. 1 — Lineage of K120839, 1997–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (3)

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	Applicant	Decided	Recalls
*	K032843	Nexiva Closed IV Catheter System Summary page 1 …atheter System is substantially equivalent to the BID NexivaTM Device cleared for U.S. commercialization via K032843 on 2/27/200, the BID Insyte® Catheter(s), cleared for US commercialization via, K971339 on…	Becton Dickinson Infusion Therapy Systems, Inc.	2004	17
*	K971339	Insyte, Insyte-W, Insyte Autoguard Catheters Summary page 1 …U.S. commercialization via K032843 on 2/27/200, the BID Insyte® Catheter(s), cleared for US commercialization via, K971339 on 12/24/1997 and the Retractable Technologies' VanishPoint®D IV Catheter…	Becton Dickinson Vascular Access, Inc.	1997	—
*	K051355	Vanishpoint I.V. Catheter Summary page 1 …12/24/1997 and the Retractable Technologies' VanishPoint®D IV Catheter , cleared for US commercialization via K051355, on 9/23/2005. Device Description: The Nova~ath TM Secure IV Catheter System is co…	Retractable Technologies, Inc.	2005	—

Also cleared against K032843: 7 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K160374	20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter…	Tangent Medical Technologies, Inc.	2016	0

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?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K160374 (Tangent Medical Technologies, Inc., 2016) has gone furthest, with 0 descendants of its own.
7 other devices also cite its predicate K032843.

How does its category compare?

All FOZ devices

FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · FOZ

11in 2025

2007high 13 (2012) · low 1 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FOZ

91in 2025

2007high 242 (2021) · low 28 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FOZ

4in 2023

2007high 115 (2010) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · FOZ

5,110in 2025

2007high 5,110 (2025) · low 370 (2010)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 TM 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 NovaCathTM may be utilized in any patient population with consideration given to vascular anatomy and appropriateness of procedure. The 18, 20 and 22 Gauge NovaCathTM devices are suitable for use with power injectors for up to a maximum of 300 psi.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K120839 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120839: Novacath Secure IV Catheter System-18G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120839

Report an extraction error

Are you the manufacturer?

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