510(k) · Cleared
ClearedEpilong Kit for Anesthesiology
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 Jun 13, 2006 as substantially equivalent to K813186 (Burron Medical Products, Inc., 1981) after a 125-day review. Its family tree reaches back 1 generation to 1981. 5 later devices descend from it.
- Decided
- Jun 13, 2006
- Review
- 125 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K813186 (1981). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK813186 Perfix Set for Epidural Anesthesia W/TuoBurron Medical Products, Inc. · 1981
- This deviceK060311 Epilong Kit for AnesthesiologyPAJUNK GmbH Medizintechnologie · 2006
- Descendant · cites it directly · 2 of its ownK062900 Pajunks Stimulong Tsui-Method SetPAJUNK GmbH Medizintechnologie · 2007
- Descendant · cites it directly · 1 of its ownK062902 Pajunks Epilong Set PediatricPAJUNK GmbH Medizintechnologie · 2007
- Descendant · 2 generations on · 0 of its ownK090884 Perifix One Pediatric Catheter, 20 GA. & 24 GA.B.Braun Medical, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK082183 Pajunk's Generic Convenience Tray for Regional Anesthesia: CSFPAJUNK GmbH Medizintechnologie · 2008
- Descendant · 2 generations on · 0 of its ownK082164 Pajunk's Generic Convenience Tray for Regional Anesthesia of the…PAJUNK GmbH Medizintechnologie · 2008
Most influential descendants
Showing 5 of 5 · See all- K062900Pajunks Stimulong Tsui-Method SetPAJUNK GmbH Medizintechnologie · 2007 · cites it directly2descendants
- K062902Pajunks Epilong Set PediatricPAJUNK GmbH Medizintechnologie · 2007 · cites it directly1descendant
- K090884Perifix One Pediatric Catheter, 20 GA. & 24 GA.B.Braun Medical, Inc. · 2009 · 2 generations on0descendants
- K082183Pajunk's Generic Convenience Tray for Regional Anesthesia: CSFPAJUNK GmbH Medizintechnologie · 2008 · cites it directly0descendants
- K082164Pajunk's Generic Convenience Tray for Regional Anesthesia of the Peripheral Plexus…PAJUNK GmbH Medizintechnologie · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K813186 | Perfix Set for Epidural Anesthesia W/Tuo | Burron Medical Products, Inc. | 1981 | — |
| 0 (this device) | K060311 | Epilong Kit for Anesthesiology | PAJUNK GmbH Medizintechnologie | 2006 | — |
| +1 | K062900 | Pajunks Stimulong Tsui-Method Set | PAJUNK GmbH Medizintechnologie | 2007 | — |
| +1 | K062902 | Pajunks Epilong Set Pediatric | PAJUNK GmbH Medizintechnologie | 2007 | — |
| +2 | K090884 | Perifix One Pediatric Catheter, 20 GA. & 24 GA. | B.Braun Medical, Inc. | 2009 | — |
| +1 | K082183 | Pajunk's Generic Convenience Tray for Regional Anesthesia: CSF | PAJUNK GmbH Medizintechnologie | 2008 | — |
| +2 | K082164 | Pajunk's Generic Convenience Tray for Regional Anesthesia of the Peripheral… | PAJUNK GmbH Medizintechnologie | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 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 CAZ? 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? (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 |
|---|---|---|---|
| * | K813186 | Perfix Set for Epidural Anesthesia W/TuoSummary page 1…ication: Proposed Product CAZ, Kit, Conduction Anesthesia Classification Code: Panel: Anesthesiology Predicate Devices: 1. BBrauns Perifix K813186 (also included in BBrauns Espocan K932400) PMN 510(k)-EpiLon- Summary-C .doc PMN… | 1981 |
| † | K040965 | Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles | 2004 |
| † | K043130 | Modification to Pajunk Stimulong Plus Catheter Sets | 2004 |
| † | K033018 | Stimulong Plus Catheter Set Model, Various | 2004 |
| † | K042979 | Modification to: Plexalong Sets | 2004 |
| † | K023218 | Modification to Plexolong Sets | 2003 |
| † | K013041 | Plexolong Sets | 2002 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 Pajunk EpiLong anesthesia conduction kit is indicated for administration of epidural anesthesia. The Pajunk catheter is placed in the epidural space to facilitate a longer anesthetic effect. After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain in the epidural space for as long as determined by the professional anesthetist and the instructions for use (up to 72 hours). The Pajunk Loss of Resistance…
Read the full statement (176 words)
The Pajunk EpiLong anesthesia conduction kit is indicated for administration of epidural anesthesia.
The Pajunk catheter is placed in the epidural space to facilitate a longer anesthetic effect.
After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain in the epidural space for as long as determined by the professional anesthetist and the instructions for use (up to 72 hours).
The Pajunk Loss of Resistance (LOR)-Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the Loss of Resistance technique as explained in standard medical textbooks.
These syringes are not intended for injection or aspiration.
The Pajunk anesthesia conduction flat filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid.
The Pajunk Tuohy Borst Adaptor is connected to the needle via Luer connector. It ensures sealing and fixation of the catheter end and allows attachment of a Luer Lock syringe or infusion device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060311: Epilong Kit for Anesthesiology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060311
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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