510(k) · Cleared
ClearedPlexolong 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 Jun 11, 2002 as substantially equivalent to K000722 (Pajunk GmbH, 2000) and 1 other predicate after a 274-day review. Its family tree reaches back 1 generation to 1984. 32 later devices descend from it.
- Decided
- Jun 11, 2002
- Review
- 274 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K840287 (1984). 2 ancestors in all. 32 later devices descend from it, 10 citing it directly.
- Root · 1 generation backK840287 Brachial Plexus Anesthesia TrayBurron Medical Products, Inc. · 1984
- This deviceK013041 Plexolong SetsPajunk GmbH · 2002
- Descendant · cites it directly · 25 of its ownK023218 Modification to Plexolong SetsPajunk GmbH · 2003
- Descendant · cites it directly · 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 · cites it directly · 11 of its ownK063380 Echostim Facet TipHavel'S, Inc. · 2007
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K023218Modification to Plexolong SetsPajunk GmbH · 2003 · cites it directly25descendants
- K033018Stimulong Plus Catheter Set Model, VariousPajunk GmbH · 2004 · cites it directly23descendants
- 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
- K063380Echostim Facet TipHavel'S, Inc. · 2007 · cites it directly11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K840287 | Brachial Plexus Anesthesia Tray | Burron Medical Products, Inc. | 1984 | — |
| 0 (this device) | K013041 | Plexolong Sets | Pajunk GmbH | 2002 | — |
| +1 | K023218 | Modification to Plexolong Sets | Pajunk GmbH | 2003 | — |
| +1 | 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 | — |
| +1 | K063380 | Echostim Facet Tip | Havel'S, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2012 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 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.
Planning a device in CAZ? 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 |
|---|---|---|---|
| * | K000722 | Unipolar NeedlesSummary page 1…stylet and catheter adapter. The Unipolar needles (with nerve stimulus connector and tubing) have been cleared for market by the FDA under 5lO(k) number K000722. The plastic cannula, front-end open tip catheter with Teflon coated stylet and catheter adapter are substantial… | 2000 |
| * | K840287 | Brachial Plexus Anesthesia TraySummary page 1…theter adapter contained in identical sets manufactured by B Braun Medical Inc. that were cleared by the Food and Drug Administration under 510(k) number K840287. The contract sterilizer and sterilizing process are identical to those used for the Pajunk Unipolar needles. Th… | 1984 |
What descends from it? (32)
See all 3210 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023218 | Modification to Plexolong Sets | 2003 | 25 |
| K033018 | Stimulong Plus Catheter Set Model, Various | 2004 | 23 |
| K063380 | Echostim Facet Tip | 2007 | 11 |
| K042979 | Modification to: Plexalong Sets | 2004 | 5 |
| K043130 | Modification to Pajunk Stimulong Plus Catheter Sets | 2004 | 4 |
| K053283 | Uniplex Nanoline Cannula, Plexolong Nanoline Set, Stimulong Nanoline Set | 2006 | 2 |
| K060563 | Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IV | 2006 | 1 |
| K052946 | MPS Acacia Nerve Block Needle | 2005 | 1 |
| K113188 | Sonolong Sono, Curl Sono, Nanoline, Brand Names Carryingsono/Sonolong | 2012 | 0 |
| K082164 | Pajunk's Generic Convenience Tray for Regional Anesthesia of the Peripheral Plexus… | 2008 | 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?
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 Plexolong sets consist of Pajunk Unipolar conduction needle with a plastic cannula placed over the needle. They are intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. Continuous delivery for up to 72 hours is accomplished using the Polyamide indwelling catheter. An electrical stimulus may be applied to the conduction needle via a cable and connector to assist the physician pinpoint the area of application.
Warning :
The Pajunk GmbH needles and puncture sets are not intended for RF ablation or any other type of ablation procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013041 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013041: Plexolong Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013041
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026