510(k) · Cleared
ClearedSonolong Sono, Curl Sono, Nanoline, Brand Names Carryingsono/Sonolong
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
PAJUNK GmbH Medizintechnologie · CAZ Anesthesia Conduction Kit
Cleared on Mar 1, 2012 as substantially equivalent to K033018 (Pajunk GmbH, 2004) and 1 other predicate after a 122-day review. Its family tree reaches back 4 generations to 1984. 1 of the 11 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 1, 2012
- Review
- 122 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K840287 (1984). 10 ancestors in all, the oldest K801912 (1980). No later device cites it as a predicate yet. 1 of the 11 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 deviceK113188 Sonolong Sono, Curl Sono, Nanoline, Brand Names Carryingsono/SonolongPAJUNK GmbH Medizintechnologie · 2012
Class I recalls in this family
- K801912 Arrow Positive Placement Con/Epidural an4 generations back · 1980
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) | K113188 | Sonolong Sono, Curl Sono, Nanoline, Brand Names Carryingsono/Sonolong | PAJUNK GmbH Medizintechnologie | 2012 | — |
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 |
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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033018 | Stimulong Plus Catheter Set Model, VariousSummary page 2…tory Class: 1 Panel: Anesthesiology 1) K033018 PA.JUNK StimuL-ong Plus Catheter sets… | 2004 |
| * | K013041 | Plexolong SetsSummary page 2…sets PAJUNK" GmbH Medizintechnologie, Geisingen 2) K01 3041 PAJUNK® PlexoLong Anaesthesia Predicate Devices: sets… | 2002 |
| Kept off the family tree | K011374 | FDA’s K011374 is Jewel MPS Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- 3 of the 10 ancestors have a recall of any class; 1 has a Class I recall.
- 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. 2012, this device’s year, is highlighted.
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® Sono-Series Kits SonoLong, SonoLong Sono, PlexoLong Sono, StimuL-ong Sono, SonoLong NanoLine and SonoLong Curl Sono are intended for delivery of continuous conduction anesthesia and/ or analgesia of peripheral nerves for up to 72 hours. Continuous delivery for up to 72 hours is accomplished using the Polyamide indwelling catheter. Optionally an electrical stimulus may be applied to assist the physician pinpoint the area of application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113188: Sonolong Sono, Curl Sono, Nanoline, Brand Names Carryingsono/Sonolong.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113188
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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