510(k) · Cleared
ClearedModification to: Plexalong Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pajunk GmbH · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Dec 21, 2004 as substantially equivalent to K013041 (Pajunk GmbH, 2002) and 2 other predicates after a 53-day review. Its family tree reaches back 3 generations to 1984. 5 later devices descend from it.
- Decided
- Dec 21, 2004
- Review
- 53 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K840287 (1984). 4 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK840287 Brachial Plexus Anesthesia TrayBurron Medical Products, Inc. · 1984
- 2 generations backK013041 Plexolong SetsPajunk GmbH · 2002
- 1 generation backK023218 Modification to Plexolong SetsPajunk GmbH · 2003
- This deviceK042979 Modification to: Plexalong SetsPajunk GmbH · 2004
- Descendant · cites it directly · 2 of its ownK053283 Uniplex Nanoline Cannula, Plexolong Nanoline Set, Stimulong Nanoline…Pajunk GmbH · 2006
- 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 ownK173110 GraftsiteSummit Medical, Ltd. · 2018
- 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
Most influential descendants
Showing 5 of 5 · See all- K053283Uniplex Nanoline Cannula, Plexolong Nanoline Set, Stimulong Nanoline SetPajunk GmbH · 2006 · cites it directly2descendants
- K060563Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IVPajunk GmbH · 2006 · cites it directly1descendant
- K173110GraftsiteSummit Medical, Ltd. · 2018 · 2 generations on0descendants
- 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 |
|---|---|---|---|---|---|
| −3 | K840287 | Brachial Plexus Anesthesia Tray | Burron Medical Products, Inc. | 1984 | — |
| −2 | K013041 | Plexolong Sets | Pajunk GmbH | 2002 | — |
| −1 | K023218 | Modification to Plexolong Sets | Pajunk GmbH | 2003 | — |
| 0 (this device) | K042979 | Modification to: Plexalong Sets | Pajunk GmbH | 2004 | — |
| +1 | K053283 | Uniplex Nanoline Cannula, Plexolong Nanoline Set, Stimulong Nanoline Set | Pajunk GmbH | 2006 | — |
| +1 | K060563 | Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IV | Pajunk GmbH | 2006 | — |
| +2 | K173110 | Graftsite | Summit Medical, Ltd. | 2018 | — |
| +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 |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2018 | 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 BSP? 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 BSP device
- #1 K241954 SonoBlock; SonoBlock IIscore 11.0 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | K013041 | Plexolong SetsSummary page 1…nnula with nerve stimulus connector and tubing), stylet, and an open end catheter and a catheter adapter. The Plexalong sets have been cleared under K01 3041 and the Unipolar needles under 51 0(k) number K000722 (facet and Sprotte tip conduction cannula and tubing). Unipolar need… | 2002 |
| * | K000722 | Unipolar NeedlesSummary page 1…stylet, and an open end catheter and a catheter adapter. The Plexalong sets have been cleared under K01 3041 and the Unipolar needles under 51 0(k) number K000722 (facet and Sprotte tip conduction cannula and tubing). Unipolar needles with a Tuohy tip were cleared for market un… | 2000 |
| * | K023218 | Modification to Plexolong SetsSummary page 1…1 0(k) number K000722 (facet and Sprotte tip conduction cannula and tubing). Unipolar needles with a Tuohy tip were cleared for market under 51 0(k) number K02321 8. The packaging materials used to package the Pajunk Plexalong sets, and needles have not changed. The contract ste… | 2003 |
| † | K033018 | Stimulong Plus Catheter Set Model, Various | 2004 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K053283 (Pajunk GmbH, 2006) has gone furthest, with 2 descendants of its own.
- 9 other devices also cite its predicate K013041.
How does its category compare?
All BSP devicesBSP Needle, Conduction, Anesthetic (W/Wo Introducer): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BSP
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSP
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSP
1in 2020
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BSP
86in 2025
MAUDE reports naming product code BSP, 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 | 3 | 189 | 0 | 26 |
| 2008 | 8 | 127 | 0 | 24 |
| 2009 | 5 | 97 | 0 | 30 |
| 2010 | 3 | 79 | 0 | 49 |
| 2011 | 3 | 114 | 0 | 33 |
| 2012 | 3 | 148 | 0 | 20 |
| 2013 | 2 | — | 0 | 32 |
| 2014 | 2 | — | 0 | 41 |
| 2015 | 2 | — | 0 | 38 |
| 2016 | 6 | 268 | 1 | 152 |
| 2017 | 4 | 186 | 0 | 34 |
| 2018 | 8 | 241 | 0 | 69 |
| 2019 | 2 | — | 1 | 86 |
| 2020 | 3 | 269 | 1 | 78 |
| 2021 | 3 | 265 | 0 | 52 |
| 2022 | 2 | — | 0 | 84 |
| 2023 | 0 | — | 0 | 75 |
| 2024 | 3 | 70 | 0 | 66 |
| 2025 | 4 | 170 | 0 | 86 |
| 2026 | 0 | — | 1 (1) | — |
What is it indicated for?
The Pajunk Plexalong Sets 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 connectors 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/K042979 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042979: Modification to: Plexalong Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042979
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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