510(k) · Cleared

Cleared

Sunder Central Venous Catheter Kit, Models SD-3L55F30J and SD-3L70F30J

K024007510(k) TraditionalCleared Jul 14, 2003222-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

Sunder Biomedical Tech. Co., Ltd. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Cleared on Jul 14, 2003 as substantially equivalent to K993691 (Arrow Intl., Inc., 2000) after a 222-day review. Its family tree reaches back 1 generation to 2000. 1 of the 4 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.

Decided: Jul 14, 2003
Review: 222 days
Class: Class II
Product code: FOZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K993691 (2000). 2 later devices descend from it, 1 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK993691 Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous…Arrow Intl., Inc. · 2000 · Recalled (Class I)
This deviceK024007 Sunder Central Venous Catheter Kit, Models SD-3L55F30J and SD-3L70F30JSunder Biomedical Tech. Co., Ltd. · 2003
Descendant · cites it directly · 1 of its ownK070451 Able Central Venous CatheterFoshan Nanhai Bai HE Medical Technology Co., Ltd. · 2007
Descendant · 2 generations on · 0 of its ownK193158 ACENT™ Central Venous CatheterGlobal Medikit Limited · 2020

Class I recalls in this family

K993691 Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen…direct predicate · 2000

Most influential descendants

Showing 2 of 2 · See all

K070451Able Central Venous CatheterFoshan Nanhai Bai HE Medical Technology Co., Ltd. · 2007 · cites it directly1descendant
K193158ACENT™ Central Venous CatheterGlobal Medikit Limited · 2020 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K993691	Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous Catheter	Arrow Intl., Inc.	2000	Class I
0 (this device)	K024007	Sunder Central Venous Catheter Kit, Models SD-3L55F30J and SD-3L70F30J	Sunder Biomedical Tech. Co., Ltd.	2003	—
+1	K070451	Able Central Venous Catheter	Foshan Nanhai Bai HE Medical Technology Co., Ltd.	2007	—
+2	K193158	ACENT™ Central Venous Catheter	Global Medikit Limited	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2020	1	0

FIG. 1 — Lineage of K024007, 2000–2020Source: 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.

1 device in this family has a Class I recall. 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

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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	Applicant	Decided	Recalls
*	K993691	Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous Catheter Summary page 1 …ascular catheter Legally marketed device to which the device is substantially equivalent ARROiV g+ and blue PlusTMMulti-Lumen Central Venous Catheter 5 1O(k) No.: K99369 1 Description of the device The medical device made by Sunder Biomedical Tech, CO., LTD are triple-lumen. polyurethane c…	Arrow Intl., Inc.	2000	Class I

Also cleared against K993691: 5 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K070451	Able Central Venous Catheter	Foshan Nanhai Bai HE Medical Technology Co., Ltd.	2007	1

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has a recall, Class I.
Of its descendants, K070451 (Foshan Nanhai Bai HE Medical Technology Co., Ltd., 2007) has gone furthest, with 1 descendant of its own.
5 other devices also cite its predicate K993691.

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.

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 triple lumen central venous Catheter is intended for vascular access infusion and withdrawal of blood, blood products, and fluids, central venous blood pressure monitoring and continuous or intermittent drug infusion. Patients requiring multiple sites for IV access. Patients lacking useable peripheral IV sites. Patients requiring central venous pressure monitoring. Patients requiring total parenteral nutrition. Patients receiving incompatible…

Read the full statement (92 words)

The triple lumen central venous Catheter is intended for vascular access infusion and

withdrawal of blood, blood products, and fluids, central venous blood pressure monitoring and

continuous or intermittent drug infusion.

Patients requiring multiple sites for IV access.

Patients lacking useable peripheral IV sites.

Patients requiring central venous pressure monitoring.

Patients requiring total parenteral nutrition.

Patients receiving incompatible medications.

Patients requiring multiple infusions of fluids, medications, or chemotherapy.

Patients subject to frequent blood sampling or receiving blood transfusions.

Patients receiving infusions that are hypertonic, hyperosmolar or infusions that have

divergent pH values.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K024007 · printed Nov 3, 2026

Cite this page

510(k) Report. “K024007: Sunder Central Venous Catheter Kit, Models SD-3L55F30J and SD-3L70F30J.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024007

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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