510(k) · Cleared
ClearedModification to Plexolong 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 Mar 24, 2003 as substantially equivalent to K013041 (Pajunk GmbH, 2002) after a 179-day review. Its family tree reaches back 2 generations to 1984. 25 later devices descend from it.
- Decided
- Mar 24, 2003
- Review
- 179 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K840287 (1984). 3 ancestors in all. 25 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK840287 Brachial Plexus Anesthesia TrayBurron Medical Products, Inc. · 1984
- 1 generation backK013041 Plexolong SetsPajunk GmbH · 2002
- This deviceK023218 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 · 4 generations on · 7 of its ownK100241 Contiplex D Continuous Nerve Block Set, Model 331687, 331686…B.Braun Medical, Inc. · 2010
- Descendant · cites it directly · 5 of its ownK042979 Modification to: Plexalong SetsPajunk GmbH · 2004
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- 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
- K100241Contiplex D Continuous Nerve Block Set, Model 331687, 331686, 331685, 331680B.Braun Medical, Inc. · 2010 · 4 generations on7descendants
- K042979Modification to: Plexalong SetsPajunk GmbH · 2004 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K840287 | Brachial Plexus Anesthesia Tray | Burron Medical Products, Inc. | 1984 | — |
| −1 | K013041 | Plexolong Sets | Pajunk GmbH | 2002 | — |
| 0 (this device) | 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 | — |
| +4 | K100241 | Contiplex D Continuous Nerve Block Set, Model 331687, 331686, 331685, 331680 | B.Braun Medical, Inc. | 2010 | — |
| +1 | K042979 | Modification to: Plexalong Sets | Pajunk GmbH | 2004 | — |
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 |
|---|---|---|
| 2004 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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.
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? (1)
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…n coated stylet), catheter adapter.and filter. The set, including the packaging is identical to the Plexolong Sets cleared for market under 510(k) number K013041, except for the Touhy needles with nerve stimulus connector. The Touhy needle is identical to the Unipolar needle, includ… | 2002 |
| † | K813186 | Perfix Set for Epidural Anesthesia W/Tuo | 1981 |
| † | K000722 | Unipolar Needles | 2000 |
What descends from it? (25)
See all 256 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033018 | Stimulong Plus Catheter Set Model, Various | 2004 | 23 |
| 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 |
| 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?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 18.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K033018 (Pajunk GmbH, 2004) has gone furthest, with 23 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 Plesolong sets are ntended 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023218 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023218: Modification to Plexolong Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023218
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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