510(k) · Cleared
Recalled · 2011Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow International, Inc. · CAZ Anesthesia Conduction Kit
Cleared on Apr 23, 2003 as substantially equivalent to K021567 (Arrow Intl., Inc., 2002) and 1 other predicate after a 29-day review. Its family tree reaches back 2 generations to 1980. 3 of the 35 devices in its family, counting itself, have a Class I recall. 29 later devices descend from it. It has been recalled once.
- Decided
- Apr 23, 2003
- Review
- 29 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K801912 (1980). 5 ancestors in all. 29 later devices descend from it, 4 citing it directly. 3 of the 35 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK801912 Arrow Positive Placement Con/Epidural anArrow Intl., Inc. · 1980 · Recalled (Class I)
- 1 generation backK021567 Stimucath Continuous Nerve Block Set, Product Number AB-05000Arrow Intl., Inc. · 2002 · Recalled
- This deviceK030937 Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060…Arrow International, Inc. · 2003
- Descendant · cites it directly · 23 of its ownK033018 Stimulong Plus Catheter Set Model, VariousPajunk GmbH · 2004
- Descendant · cites it directly · 13 of its ownK063282 Contiplex Stim Continuous Nerve Block SetB.Braun Medical, Inc. · 2007
- Descendant · 2 generations on · 12 of its ownK090995 B. Braun Contiplex Continuous Nerve Block SetB.Braun Medical, Inc. · 2009
- Descendant · 3 generations on · 7 of its ownK100241 Contiplex D Continuous Nerve Block Set, Model 331687, 331686…B.Braun Medical, Inc. · 2010
- Descendant · 2 generations on · 4 of its ownK043130 Modification to Pajunk Stimulong Plus Catheter SetsPajunk GmbH · 2004
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 29 · See all- K033018Stimulong Plus Catheter Set Model, VariousPajunk GmbH · 2004 · cites it directly23descendants
- K063282Contiplex Stim Continuous Nerve Block SetB.Braun Medical, Inc. · 2007 · cites it directly13descendants
- K090995B. Braun Contiplex Continuous Nerve Block SetB.Braun Medical, Inc. · 2009 · 2 generations on12descendants
- K100241Contiplex D Continuous Nerve Block Set, Model 331687, 331686, 331685, 331680B.Braun Medical, Inc. · 2010 · 3 generations on7descendants
- K043130Modification to Pajunk Stimulong Plus Catheter SetsPajunk GmbH · 2004 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K801912 | Arrow Positive Placement Con/Epidural an | Arrow Intl., Inc. | 1980 | Class I |
| −1 | K021567 | Stimucath Continuous Nerve Block Set, Product Number AB-05000 | Arrow Intl., Inc. | 2002 | 2 |
| 0 (this device) | K030937 | Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060, AB-02090… | Arrow International, Inc. | 2003 | — |
| +1 | K033018 | Stimulong Plus Catheter Set Model, Various | Pajunk GmbH | 2004 | — |
| +1 | K063282 | Contiplex Stim Continuous Nerve Block Set | B.Braun Medical, Inc. | 2007 | — |
| +2 | K090995 | B. Braun Contiplex Continuous Nerve Block Set | B.Braun Medical, Inc. | 2009 | — |
| +3 | K100241 | Contiplex D Continuous Nerve Block Set, Model 331687, 331686, 331685, 331680 | B.Braun Medical, Inc. | 2010 | — |
| +2 | K043130 | Modification to Pajunk Stimulong Plus Catheter Sets | Pajunk GmbH | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2006 | 2 | 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 |
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
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K021567 | Stimucath Continuous Nerve Block Set, Product Number AB-05000Summary page 1…Device classification name: CAZ,Class II, 21 CFR 868.5140, Anesthetic conduction kit. Legally marketed devices to - Arrow StimuCath" continuous nerve block set (K021567). which the device is - HDC@Corporation CLA" regional block needle (K994059). substantially equivalent:… | 2002 |
| * | K994059 | Cla Kit (Continuous Local Anesthesia), Model 551-17, 551-10, 551-07Summary page 1…Legally marketed devices to - Arrow StimuCath" continuous nerve block set (K021567). which the device is - HDC@Corporation CLA" regional block needle (K994059). substantially equivalent: Description of the device: The StimuCath" continuous nerve block device is an… | 2000 |
What descends from it? (29)
See all 294 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 17, 2011 | Not classified | Z-2894-2011 | Packaging | Some of the outer trays used in the packaging were found to have an insufficient seal. Therefore, packaging may have been compromised, and sterility of the product cannot be guaranteed. |
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 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K121403Continuous Peripheral Nerve Block Catheter Kit and SetTeleflex, Inc. · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K122027Arrow Flexblock Continuous Peripheral Nerve Block CatheterArrow International, Inc. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 21.8 years on median.
- 2 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K033018 (Pajunk GmbH, 2004) has gone furthest, with 23 descendants of its own.
- 2 other devices also cite its predicate K021567.
How does its category compare?
All CAZ devicesCAZ Anesthesia Conduction Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CAZ
108in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAZ
1in 2024
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · CAZ
137in 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 StimuCath" continuous 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/K030937 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030937: Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060, AB-02090, AB-02030-PK, AB-02060-PK, AB-02090-PK.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030937
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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