510(k) · Cleared
ClearedModification to Pajunk Stimulong Plus Catheter Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pajunk GmbH · CAZ Anesthesia Conduction Kit
Cleared on Dec 21, 2004 as substantially equivalent to K033018 (Pajunk GmbH, 2004) and 3 other predicates after a 39-day review. Its family tree reaches back 4 generations to 1984. 1 of the 15 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Dec 21, 2004
- Review
- 39 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K840287 (1984). 10 ancestors in all, the oldest K801912 (1980). 4 later devices descend from it, 3 citing it directly. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK840287 Brachial Plexus Anesthesia TrayBurron Medical Products, Inc. · 1984
- 3 generations backK013041 Plexolong SetsPajunk GmbH · 2002
- 2 generations backK023218 Modification to Plexolong SetsPajunk GmbH · 2003
- 1 generation backK033018 Stimulong Plus Catheter Set Model, VariousPajunk GmbH · 2004
- This deviceK043130 Modification to Pajunk Stimulong Plus Catheter SetsPajunk GmbH · 2004
- Descendant · cites it directly · 2 of its ownK062900 Pajunks Stimulong Tsui-Method SetPAJUNK GmbH Medizintechnologie · 2007
- Descendant · cites it directly · 1 of its ownK060563 Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IVPajunk GmbH · 2006
- Descendant · 2 generations on · 0 of its ownK082183 Pajunk's Generic Convenience Tray for Regional Anesthesia: CSFPAJUNK GmbH Medizintechnologie · 2008
- Descendant · cites it directly · 0 of its ownK082164 Pajunk's Generic Convenience Tray for Regional Anesthesia of the…PAJUNK GmbH Medizintechnologie · 2008
Class I recalls in this family
- K801912 Arrow Positive Placement Con/Epidural an4 generations back · 1980
Most influential descendants
Showing 4 of 4 · See all- K062900Pajunks Stimulong Tsui-Method SetPAJUNK GmbH Medizintechnologie · 2007 · cites it directly2descendants
- K060563Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IVPajunk GmbH · 2006 · cites it directly1descendant
- K082183Pajunk's Generic Convenience Tray for Regional Anesthesia: CSFPAJUNK GmbH Medizintechnologie · 2008 · 2 generations on0descendants
- K082164Pajunk's Generic Convenience Tray for Regional Anesthesia of the Peripheral Plexus…PAJUNK GmbH Medizintechnologie · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K840287 | Brachial Plexus Anesthesia Tray | Burron Medical Products, Inc. | 1984 | — |
| −3 | K013041 | Plexolong Sets | Pajunk GmbH | 2002 | — |
| −2 | K023218 | Modification to Plexolong Sets | Pajunk GmbH | 2003 | — |
| −1 | K033018 | Stimulong Plus Catheter Set Model, Various | Pajunk GmbH | 2004 | — |
| 0 (this device) | K043130 | Modification to Pajunk Stimulong Plus Catheter Sets | Pajunk GmbH | 2004 | — |
| +1 | K062900 | Pajunks Stimulong Tsui-Method Set | PAJUNK GmbH Medizintechnologie | 2007 | — |
| +1 | K060563 | Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IV | Pajunk GmbH | 2006 | — |
| +2 | K082183 | Pajunk's Generic Convenience Tray for Regional Anesthesia: CSF | PAJUNK GmbH Medizintechnologie | 2008 | — |
| +1 | K082164 | Pajunk's Generic Convenience Tray for Regional Anesthesia of the Peripheral… | PAJUNK GmbH Medizintechnologie | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 1 |
| 1983 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 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.
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 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? (4)
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 |
|---|---|---|---|
| * | K033018 | Stimulong Plus Catheter Set Model, VariousSummary page 1…in the Plexalong sets except for the conductive ring tip. The Stimulong Plus Catheter sets have been cleared for market by the FDA under 510(k) number K033018. The Plexalong sets have been cleared under K013041 and the Unipolar needles under 510(k) number K000722 (facet and S… | 2004 |
| * | K013041 | Plexolong SetsSummary page 1…ve ring tip. The Stimulong Plus Catheter sets have been cleared for market by the FDA under 510(k) number K033018. The Plexalong sets have been cleared under K013041 and the Unipolar needles under 510(k) number K000722 (facet and Sprotte tip conduction cannula and tubing). Unipolar… | 2002 |
| * | K000722 | Unipolar NeedlesSummary page 1…en cleared for market by the FDA under 510(k) number K033018. The Plexalong sets have been cleared under K013041 and the Unipolar needles under 510(k) number K000722 (facet and Sprotte tip conduction cannula and tubing). Unipolar needles with a Tuohy tip were cleared for market unde… | 2000 |
| * | K023218 | Modification to Plexolong SetsSummary page 1…er 510(k) number K000722 (facet and Sprotte tip conduction cannula and tubing). Unipolar needles with a Tuohy tip were cleared for market under 510(k) number K023218. The packaging materials used to package the Stimulong Plus Catheter, Pajunk Plexolong sets, and cannula has not ch… | 2003 |
| † | K030937 | Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060, AB-02090, AB-02030-PK… | 2003 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K801912Arrow Positive Placement Con/Epidural anArrow Intl., Inc. · 1980 · 4 generations back · ◆ in the 1980 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 10 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K062900 (PAJUNK GmbH Medizintechnologie, 2007) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K033018.
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 Pajunk Stimulong Plus Catheter Sets are intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. Continuous delivery is accomplished using the conduction catheter. To assist the physician pinpoint the area of application an electrical stimulus can be applied to the conduction needle and after placement of the conduction cathter to its tip via the catheter adapter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043130: Modification to Pajunk Stimulong Plus Catheter Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043130
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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