510(k) · Cleared
ClearedUniplex Nanoline Cannula, Plexolong Nanoline Set, Stimulong Nanoline Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pajunk GmbH · CAZ Anesthesia Conduction Kit
Cleared on Jan 12, 2006 as substantially equivalent to K000722 (Pajunk GmbH, 2000) and 5 other predicates after a 48-day review. Its family tree reaches back 4 generations to 1984. 1 of the 14 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Jan 12, 2006
- Review
- 48 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K840287 (1984). 11 ancestors in all, the oldest K801912 (1980). 2 later devices descend from it, 2 citing it directly. 1 of the 14 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 deviceK053283 Uniplex Nanoline Cannula, Plexolong Nanoline Set, Stimulong Nanoline…Pajunk GmbH · 2006
- Descendant · cites it directly · 0 of its ownK173110 GraftsiteSummit Medical, Ltd. · 2018
- 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
- K801912 Arrow Positive Placement Con/Epidural an4 generations back · 1980
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 |
|---|---|---|---|---|---|
| −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) | K053283 | Uniplex Nanoline Cannula, Plexolong Nanoline Set, Stimulong Nanoline Set | Pajunk GmbH | 2006 | — |
| +1 | K173110 | Graftsite | Summit Medical, Ltd. | 2018 | — |
| +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 |
| 1983 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 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.
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? (6)
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 |
|---|---|---|---|
| * | K000722 | Unipolar NeedlesSummary page 1…Classification Reference: 21 CFR 868.5140, April 1. 2003 Poposed Classification: Regulatory Class: II Proposed Product Code: CAZ Predicate Devices: 1. K000722: Pajunk's Unipolar needles (UniPlex facet & Sprotte tip) 2. K0… | 2000 |
| * | K023218 | Modification to Plexolong SetsSummary page 1…Predicate Devices: 1. K000722: Pajunk's Unipolar needles (UniPlex facet & Sprotte tip) 2. K023218: Pajunk's Unipolar needles (UniPlex Tuohy tip) 3. K033018: Pajunk's StimuLong set… | 2003 |
| * | K033018 | Stimulong Plus Catheter Set Model, VariousSummary page 1…Sprotte tip) 2. K023218: Pajunk's Unipolar needles (UniPlex Tuohy tip) 3. K033018: Pajunk's StimuLong set 4. K013041, K023218 and K042979: Pajunk's PlexoLong set… | 2004 |
| * | K013041 | Plexolong SetsSummary page 1…2. K023218: Pajunk's Unipolar needles (UniPlex Tuohy tip) 3. K033018: Pajunk's StimuLong set 4. K013041, K023218 and K042979: Pajunk's PlexoLong set 5. K994059: HDC's Insul-Cote PTM needles and CLA kit… | 2002 |
| * | K042979 | Modification to: Plexalong SetsSummary page 1…Pajunk's Unipolar needles (UniPlex Tuohy tip) 3. K033018: Pajunk's StimuLong set 4. K013041, K023218 and K042979: Pajunk's PlexoLong set 5. K994059: HDC's Insul-Cote PTM needles and CLA kit… | 2004 |
| * | K994059 | Cla Kit (Continuous Local Anesthesia), Model 551-17, 551-10, 551-07Summary page 1…3. K033018: Pajunk's StimuLong set 4. K013041, K023218 and K042979: Pajunk's PlexoLong set 5. K994059: HDC's Insul-Cote PTM needles and CLA kit (nerve stimulation), includes HDC's Neuro-Trace insu… | 2000 |
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? (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 22 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 11 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K173110 (Summit Medical, Ltd., 2018) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K000722.
How does its category compare?
All CAZ devicesCAZ Anesthesia Conduction Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 change of coating material from lacqueur to Parylene does not affect the Indications for use of the predicated devices marketed under
K042979 (Pajunk Plexolong Sets)
K033018 (Pajunk Stimulong Plus Catheter Sets)
K023218 (Pajunk Plexolong Sets)
K013041 (Pajunk Plexolong Anesthesia Sets)
K000722 (Unipolar Needles with Standard and Sprotte-tip)
The change in coating has no effect on the Indications for use of these devices already cleared for market.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053283 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053283: Uniplex Nanoline Cannula, Plexolong Nanoline Set, Stimulong Nanoline Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053283
Report an extraction error
Are you the manufacturer?
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