510(k) · Cleared
ClearedPajunk's Generic Convenience Tray for Regional Anesthesia: CSF
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 Oct 28, 2008 as substantially equivalent to K060311 (PAJUNK GmbH Medizintechnologie, 2006) and 2 other predicates after an 88-day review. Its family tree reaches back 6 generations to 1984. 3 of the 26 devices in its family, counting itself, have a Class I recall.
- Decided
- Oct 28, 2008
- Review
- 88 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K840287 (1984). 25 ancestors in all, the oldest K801912 (1980). No later device cites it as a predicate yet. 3 of the 26 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK840287 Brachial Plexus Anesthesia TrayBurron Medical Products, Inc. · 1984
- 5 generations backK013041 Plexolong SetsPajunk GmbH · 2002
- 4 generations backK023218 Modification to Plexolong SetsPajunk GmbH · 2003
- 3 generations backK033018 Stimulong Plus Catheter Set Model, VariousPajunk GmbH · 2004
- 2 generations backK043130 Modification to Pajunk Stimulong Plus Catheter SetsPajunk GmbH · 2004
- 1 generation backK060563 Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IVPajunk GmbH · 2006
- This deviceK082183 Pajunk's Generic Convenience Tray for Regional Anesthesia: CSFPAJUNK GmbH Medizintechnologie · 2008
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K840287 | Brachial Plexus Anesthesia Tray | Burron Medical Products, Inc. | 1984 | — |
| −5 | K013041 | Plexolong Sets | Pajunk GmbH | 2002 | — |
| −4 | K023218 | Modification to Plexolong Sets | Pajunk GmbH | 2003 | — |
| −3 | K033018 | Stimulong Plus Catheter Set Model, Various | Pajunk GmbH | 2004 | — |
| −2 | K043130 | Modification to Pajunk Stimulong Plus Catheter Sets | Pajunk GmbH | 2004 | — |
| −1 | K060563 | Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IV | Pajunk GmbH | 2006 | — |
| 0 (this device) | K082183 | Pajunk's Generic Convenience Tray for Regional Anesthesia: CSF | 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 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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.
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? (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 |
|---|---|---|---|
| * | K060311 | Epilong Kit for AnesthesiologySummary page 1…blishment Registration Number: 9611612 Regulatory Class: 11 Product Code: CAZ Panel: Anesthesiology Predicate devices K060311 Epillong K060663 EpiSpIn K062900 Stimul-ong Tsui Method PMN Spinal Conven… | 2006 |
| * | K060563 | Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IV Our reading of the summary gave K060663, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “EpiSpin”. | 2006 |
| * | K062900 | Pajunks Stimulong Tsui-Method SetSummary page 1…: CAZ Panel: Anesthesiology Predicate devices K060311 Epillong K060663 EpiSpIn K062900 Stimul-ong Tsui Method PMN Spinal Convenien~e Kit R&D Resp. SAG… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 5 generations back · ◆ in the 1980 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 5 of the 25 ancestors have a recall of any class; 3 have a Class I recall.
- 2 other devices also cite its predicate K060311.
How does its category compare?
All CAZ devicesCAZ Anesthesia Conduction Kit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Epidural single shot is intended for the administration of regional anaesthesia to the epidural space employing single-shot technique also including optional localization via electrical stimulus. Only needles cleared for the Intended use are part of the convenience Kit. Additional types already cleared for market may be added. PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: CSF is…
Read the full statement (352 words)
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Epidural single shot is intended for the administration of regional anaesthesia to the epidural space employing single-shot technique also including optional localization via electrical stimulus.
Only needles cleared for the Intended use are part of the convenience Kit. Additional types already cleared for market may be added.
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: CSF is intended for the administration of spinal, epidural or combined spinal-epidural regional anaesthesia, single-shot or continuous technique, optional localization via electrical stimulus.
Only needles cleared for the Intended use are part of the convenience Kit. Additional types already cleared for market may be added.
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Spinal single shot is intended for the administration of regional anaesthesia to the spinal space employing single-shot technique also including optional localization via electrical stimulus.
Only needles cleared for the Intended use are part of the convenience Kit. Additional types already cleared for market may be added.
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Epidural continuous is intended for the administration of regional anaesthesia to the epidural space employing continuous technique also including optional localization via electrical stimulus.
Only needles cleared for the Intended use are part of the convenience Kit. Additional types already cleared for market may be added.
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Spinal continuous is intended for the administration of regional anaesthesia to the epidural space employing continuous technique also including optional localization via electrical stimulus.
Only needles cleared for the Intended use are part of the convenience Kit. Additional types already cleared for market may be added.
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: CSE is intended for the administration of anaesthesia via CSE-technique, single-shot/ continuous technique, optional localization via electrical stimulus.
Only needles cleared for the Intended use are part of the convenience Kit. Additional types already cleared for market may be added.
PAJUNK®'s Generic Convenience Tray for Regional Anesthesia: Common Procedure supply is intended to support the administration of spinal, epidural and CSE-technique applied anaethesia, single-shot/ continuous technique, optional localization via electrical stimulus regional anaethesia. Neither needle nor catheter is included.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082183: Pajunk's Generic Convenience Tray for Regional Anesthesia: CSF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082183
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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