510(k) · Cleared
ClearedPajunks Stimulong Tsui-Method Set
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 Jan 12, 2007 as substantially equivalent to K033018 (Pajunk GmbH, 2004) and 4 other predicates after a 107-day review. Its family tree reaches back 5 generations to 1984. 3 of the 24 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Jan 12, 2007
- Review
- 107 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K840287 (1984). 21 ancestors in all, the oldest K801912 (1980). 2 later devices descend from it, 2 citing it directly. 3 of the 24 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK840287 Brachial Plexus Anesthesia TrayBurron Medical Products, Inc. · 1984
- 4 generations backK013041 Plexolong SetsPajunk GmbH · 2002
- 3 generations backK023218 Modification to Plexolong SetsPajunk GmbH · 2003
- 2 generations backK033018 Stimulong Plus Catheter Set Model, VariousPajunk GmbH · 2004
- 1 generation backK043130 Modification to Pajunk Stimulong Plus Catheter SetsPajunk GmbH · 2004
- This deviceK062900 Pajunks Stimulong Tsui-Method SetPAJUNK GmbH Medizintechnologie · 2007
- Descendant · cites it directly · 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
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K840287 | Brachial Plexus Anesthesia Tray | Burron Medical Products, Inc. | 1984 | — |
| −4 | K013041 | Plexolong Sets | Pajunk GmbH | 2002 | — |
| −3 | K023218 | Modification to Plexolong Sets | Pajunk GmbH | 2003 | — |
| −2 | K033018 | Stimulong Plus Catheter Set Model, Various | Pajunk GmbH | 2004 | — |
| −1 | K043130 | Modification to Pajunk Stimulong Plus Catheter Sets | Pajunk GmbH | 2004 | — |
| 0 (this device) | K062900 | Pajunks Stimulong Tsui-Method Set | PAJUNK GmbH Medizintechnologie | 2007 | — |
| +1 | 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 |
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1991 | 1 | 1 |
| 1992 | 2 | 1 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
3 devices in this family have 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? (5)
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…sification: cgulatory Class Il Proposed Product Classification Code: CAZ, Kit, Conduction Anesthesia Panel: Anesthesiology Predicate Devices: 1. Pajunks StimuLong Set K033018, K043130 2. Pajunks EpiLong Set K060311 K062900 078 Pajunks Stimul-ong Tsui Method Set Prema… | 2004 |
| * | K043130 | Modification to Pajunk Stimulong Plus Catheter SetsSummary page 1…n: cgulatory Class Il Proposed Product Classification Code: CAZ, Kit, Conduction Anesthesia Panel: Anesthesiology Predicate Devices: 1. Pajunks StimuLong Set K033018, K043130 2. Pajunks EpiLong Set K060311 K062900 078 Pajunks Stimul-ong Tsui Method Set Premarket Noti… | 2004 |
| * | K000722 | Unipolar NeedlesSummary page 3…antial equivalence with are Pajunks StimuLong Set and UP carnulas cleared under K000722, K033018, K043130, K 040965 and Pajunks EpiLong… | 2000 |
| * | K040965 | Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford NeedlesSummary page 3…Pajunks StimuLong Set and UP carnulas cleared under K000722, K033018, K043130, K 040965 and Pajunks EpiLong Set cleared un… | 2004 |
| * | K060311 | Epilong Kit for AnesthesiologySummary page 1…Product Classification Code: CAZ, Kit, Conduction Anesthesia Panel: Anesthesiology Predicate Devices: 1. Pajunks StimuLong Set K033018, K043130 2. Pajunks EpiLong Set K060311 K062900 078 Pajunks Stimul-ong Tsui Method Set Premarket Notification Submission… | 2006 |
| † | K053283 | Uniplex Nanoline Cannula, Plexolong Nanoline Set, Stimulong Nanoline Set | 2006 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 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.
- K911202Atraumatic Standard Sprotte NeedlePajunk GmbH · 1992 · 2 generations back · ◆ in the 1992 ancestors bar of FIG. 11 Class I recall
- K911260Atraumatic Standard Sprotte NeedlePajunk GmbH · 1991 · 2 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
- 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 23 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 5 of the 21 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K082183 (PAJUNK GmbH Medizintechnologie, 2008) has gone furthest, with 0 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. 2007, 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 StimuLong Tsui-Method Sets are intended for delivery of continuous conduction anesthesia to epidural space as well as optional to peripheral nerves and plexus. The catheter has to be removed or replaced after 72 hours. Continuous delivery is accomplished using the conduction catheter. To assist the physician to precisely and safe pinpoint the area of application in peripheral use an electrical stimulus can be applied to the conduction needle.…
Read the full statement (369 words)
The Pajunk StimuLong Tsui-Method Sets are intended for delivery of continuous conduction anesthesia to epidural space as well as optional to peripheral nerves and plexus.
The catheter has to be removed or replaced after 72 hours.
Continuous delivery is accomplished using the conduction catheter. To assist the physician to precisely and safe pinpoint the area of application in peripheral use an electrical stimulus can be applied to the conduction needle.
After placement of the conduction catheter in epidural space or peripheral an electrical stimulus can be applied to its tip via the catheter adapter.
The set is to be used with adults and in pediatrics.
The Pajunk epidural (optional: peripheral) stimulation catheter is placed inthe epidural space (otional: peripheral) to precisely identify the target area and to facilitate a longer anesthetic effect.
After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain for as long as determined by the professional anesthetist and the instructions for use. It has to be removed or replaced after 72 hours.
The Pajunk epidural stimulation catheter is placed in the epidural space to precisely identify the target area and to facilitate a longer anesthetic effect.
After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain for as long as determined by the professional anesthetist and the instructions for use. It has to be removed or replaced after 72 hours.
The Pajunk peripheral stimulation catheter is placed peripheral to precisely identify the target area and to facilitate a longer anesthetic effect.
After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain for as long as determined by the professional anesthetist and the instructions for use. It has to be removed or replaced after 72 hours.
Pajunks Stimulation Adapter and Adapter cables are accessories to Pajunks sets for epidural and peripheral anesthesia conduction and stimulation, for example StimuLong and StimuLong Tsui-Method.
Pajunks injection valve and injection hose are accessories to Pajunks sets for epidural and peripheral anesthesia conduction and optional stimulation, for example StimuLong and StimuLong Tsui-Method.
Pajunks peripheral NanoLine-coated cannulas are accessories to Pajunks sets for peripheral anesthesia conduction and stimulation, for example StimuLong and StimuLong Tsui-Method.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K062900 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062900: Pajunks Stimulong Tsui-Method Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062900
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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