510(k) · Cleared

Recalled · 2011

Stimucath Continuous Nerve Block Set, Product Number AB-05000

K021567510(k) TraditionalCleared Jun 19, 200237-day reviewClass II21 CFR 868.5140Recalls 2

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

Arrow Intl., Inc. · CAZ Anesthesia Conduction Kit

Cleared on Jun 19, 2002 as substantially equivalent to K801912 (Arrow Intl., Inc., 1980) and 2 other predicates after a 37-day review. Its family tree reaches back 1 generation to 1980. 3 of the 36 devices in its family, counting itself, have a Class I recall. 32 later devices descend from it. It has been recalled 2 times.

Decided: Jun 19, 2002
Review: 37 days
Class: Class II
Product code: CAZ
Recalls: 2
Predicates: 3

Its longest line of descent runs back 1 generation to K801912 (1980). 3 ancestors in all. 32 later devices descend from it, 3 citing it directly. 3 of the 36 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK801912 Arrow Positive Placement Con/Epidural anArrow Intl., Inc. · 1980 · Recalled (Class I)
This deviceK021567 Stimucath Continuous Nerve Block Set, Product Number AB-05000Arrow Intl., Inc. · 2002
Descendant · cites it directly · 29 of its ownK030937 Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060…Arrow International, Inc. · 2003 · Recalled
Descendant · 2 generations on · 23 of its ownK033018 Stimulong Plus Catheter Set Model, VariousPajunk GmbH · 2004
Descendant · 2 generations on · 13 of its ownK063282 Contiplex Stim Continuous Nerve Block SetB.Braun Medical, Inc. · 2007
Descendant · 3 generations on · 12 of its ownK090995 B. Braun Contiplex Continuous Nerve Block SetB.Braun Medical, Inc. · 2009
Descendant · 4 generations on · 7 of its ownK100241 Contiplex D Continuous Nerve Block Set, Model 331687, 331686…B.Braun Medical, Inc. · 2010

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2003high 5 (2012) · low 0 (2005)2026

Class I recalls in this family

K801912 Arrow Positive Placement Con/Epidural andirect predicate · 1980
K121403 Continuous Peripheral Nerve Block Catheter Kit…2 generations on · 2012
K122027 Arrow Flexblock Continuous Peripheral Nerve…3 generations on · 2012

Most influential descendants

Showing 5 of 32 · See all

K030937Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060, AB-02090, AB-02030-PK…Arrow International, Inc. · 2003 · cites it directly29descendants
K033018Stimulong Plus Catheter Set Model, VariousPajunk GmbH · 2004 · 2 generations on23descendants
K063282Contiplex Stim Continuous Nerve Block SetB.Braun Medical, Inc. · 2007 · 2 generations on13descendants
K090995B. Braun Contiplex Continuous Nerve Block SetB.Braun Medical, Inc. · 2009 · 3 generations on12descendants
K100241Contiplex D Continuous Nerve Block Set, Model 331687, 331686, 331685, 331680B.Braun Medical, Inc. · 2010 · 4 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K801912	Arrow Positive Placement Con/Epidural an	Arrow Intl., Inc.	1980	Class I
0 (this device)	K021567	Stimucath Continuous Nerve Block Set, Product Number AB-05000	Arrow Intl., Inc.	2002	—
+1	K030937	Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060, AB-02090…	Arrow International, Inc.	2003	1
+2	K033018	Stimulong Plus Catheter Set Model, Various	Pajunk GmbH	2004	—
+2	K063282	Contiplex Stim Continuous Nerve Block Set	B.Braun Medical, Inc.	2007	—
+3	K090995	B. Braun Contiplex Continuous Nerve Block Set	B.Braun Medical, Inc.	2009	—
+4	K100241	Contiplex D Continuous Nerve Block Set, Model 331687, 331686, 331685, 331680	B.Braun Medical, Inc.	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1983	1	0
1984	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	2	0
2006	3	0
2007	2	0
2008	2	0
2009	1	0
2010	1	0
2012	5	2
2014	2	0
2015	1	0
2016	2	0
2017	1	0
2018	2	0
2020	3	0
2022	1	0
2023	1	0
2024	1	0

FIG. 1 — Lineage of K021567, 1980–2024Source: 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.

3 devices in this family have 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 CAZ device

#1 K261372 Profoject™ LOR Syringescore 12.4 · 2 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
*	K801912	Arrow Positive Placement Con/Epidural an Summary page 1 …Peripheral nerve stimulating catheter and needle Device classification CAZ, Class I1at 21 CFR 868.5140, Anesthetic Conduction Kit name: Legally marketed devices K801912: Arrow TheraCathB Epidural Catheter to which the device is K831715: HDC Corp Neurotrac substantially equivalent:…	Arrow Intl., Inc.	1980	Class I
*	K831715	Neurotrac Summary page 1 …ion CAZ, Class I1at 21 CFR 868.5140, Anesthetic Conduction Kit name: Legally marketed devices K801912: Arrow TheraCathB Epidural Catheter to which the device is K831715: HDC Corp Neurotrac substantially equivalent: K840287: Contiplex Continuous Nerve Block Set Description…	Hdc Corp.	1983	—
*	K840287	Brachial Plexus Anesthesia Tray Summary page 1 …ly marketed devices K801912: Arrow TheraCathB Epidural Catheter to which the device is K831715: HDC Corp Neurotrac substantially equivalent: K840287: Contiplex Continuous Nerve Block Set Description of device: The StimuCathTMContinuous Nerve Block Device is an…	Burron Medical Products, Inc.	1984	—

Also cleared against K801912: 1 other device →

What descends from it? (32)

See all 32

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K030937	Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060, AB-02090, AB-02030-PK…	Arrow International, Inc.	2003	29
K060186	Polyplex Stimulating Catheter System	Te ME NA Sas	2006	0
K022752	Pandin Continuous Nerve Stimulating Catheter, Models 561-18-05, 561-18-09, 561-18-15…	Hdc Corp.	2003	0

Has anything in its family been recalled? (3 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 20, 2011	Not classified	Z-0309-2012	Packaging	Some of the outer trays used in the packaging of the ASK-19608-SFH Continuous Nerve Block Kits, lot # MF0127039 were found to have an insufficient seal. Therefore, the packaging may have been compromised, and sterility of the product…
Feb 17, 2005	Not classified	Z-0852-05	Other	Possible difficulty in passing the catheter through the needle due to a reduced ID of the needle caused by over crimping of the needle during the manufacturing process.

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.

K801912Arrow Positive Placement Con/Epidural anArrow Intl., Inc. · 1980 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K121403Continuous Peripheral Nerve Block Catheter Kit and SetTeleflex, Inc. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
K122027Arrow Flexblock Continuous Peripheral Nerve Block CatheterArrow International, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall

What does this lineage say?

1 of the 3 ancestors has a recall of any class; 1 has a Class I recall.
Of its descendants, K030937 (Arrow International, Inc., 2003) has gone furthest, with 29 descendants of its own.
1 other device also cites its predicate K801912.

How does its category compare?

All CAZ devices

CAZ Anesthesia Conduction Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CAZ

1in 2023

2007high 9 (2012) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAZ

108in 2012

2007high 172 (2007) · low 99 (2008)2026

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

Recalls per year · CAZ

1in 2024

2007high 29 (2009) · low 0 (2007)2026

Class I (11 since 2007) Class II/III not classified

Adverse event reports per year · CAZ

137in 2025

2007high 472 (2019) · low 60 (2023)2025

MAUDE reports naming product code CAZ, 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	4	172	0	81
2008	4	99	0	80
2009	2	—	29	134
2010	2	—	8	139
2011	1	—	2	187
2012	9	108	0	187
2013	0	—	12	276
2014	0	—	2	251
2015	1	—	1	235
2016	2	—	1	372
2017	0	—	0	353
2018	0	—	0	448
2019	1	—	0	472
2020	1	—	0	274
2021	1	—	0	165
2022	1	—	0	270
2023	1	—	0	60
2024	0	—	1	165
2025	0	—	0	137
2026	1	—	12 (11)	—

What is it indicated for?

The Arrow StimuCathTMContinuous Nerve Block Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021567 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021567: Stimucath Continuous Nerve Block Set, Product Number AB-05000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021567

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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