510(k) · Cleared
ClearedEpispin, Epispin II Safety, Epispin II, Epispin I, Epispin IV
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 Jun 2, 2006 as substantially equivalent to K043130 (Pajunk GmbH, 2004) and 10 other predicates after a 114-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. 1 later device descends from it.
- Decided
- Jun 2, 2006
- Review
- 114 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 5 generations to K840287 (1984). 22 ancestors in all, the oldest K801912 (1980). 1 later device descends from it, 1 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 deviceK060563 Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IVPajunk GmbH · 2006
- Descendant · cites it directly · 0 of its ownK082183 Pajunk's Generic Convenience Tray for Regional Anesthesia: CSFPAJUNK GmbH Medizintechnologie · 2008
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K082183Pajunk's Generic Convenience Tray for Regional Anesthesia: CSFPAJUNK GmbH Medizintechnologie · 2008 · cites it directly0descendants
View 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) | K060563 | Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IV | Pajunk GmbH | 2006 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (11)
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 |
|---|---|---|---|
| * | K043130 | Modification to Pajunk Stimulong Plus Catheter SetsSummary page 1…868.5140, April 1, 2005, Poposed Classification: Proposed Product Classification Code: Panel: Anesthesiology Predicate Devices: 1. Pajunks Stimulong Plus Plexus Catheter K043130, K033018 2. Pajunks Plexolong Sets K042979, K023218, K013041 3. Pajunk Sprotte and various Anesthesia conduction cannulas K040965… | 2004 |
| * | K033018 | Stimulong Plus Catheter Set Model, VariousSummary page 1…April 1, 2005, Poposed Classification: Proposed Product Classification Code: Panel: Anesthesiology Predicate Devices: 1. Pajunks Stimulong Plus Plexus Catheter K043130, K033018 2. Pajunks Plexolong Sets K042979, K023218, K013041 3. Pajunk Sprotte and various Anesthesia conduction cannulas K040965, K911202… | 2004 |
| * | K042979 | Modification to: Plexalong SetsSummary page 1…tion: Proposed Product Classification Code: Panel: Anesthesiology Predicate Devices: 1. Pajunks Stimulong Plus Plexus Catheter K043130, K033018 2. Pajunks Plexolong Sets K042979, K023218, K013041 3. Pajunk Sprotte and various Anesthesia conduction cannulas K040965, K911202, K911260, K911221 4. BBrauns Esp… | 2004 |
| * | K023218 | Modification to Plexolong SetsSummary page 1…posed Product Classification Code: Panel: Anesthesiology Predicate Devices: 1. Pajunks Stimulong Plus Plexus Catheter K043130, K033018 2. Pajunks Plexolong Sets K042979, K023218, K013041 3. Pajunk Sprotte and various Anesthesia conduction cannulas K040965, K911202, K911260, K911221 4. BBrauns Espocan K932… | 2003 |
| * | K013041 | Plexolong SetsSummary page 1…duct Classification Code: Panel: Anesthesiology Predicate Devices: 1. Pajunks Stimulong Plus Plexus Catheter K043130, K033018 2. Pajunks Plexolong Sets K042979, K023218, K013041 3. Pajunk Sprotte and various Anesthesia conduction cannulas K040965, K911202, K911260, K911221 4. BBrauns Espocan K932400 (incl… | 2002 |
| * | K040965 | Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford NeedlesSummary page 1…Pajunks Stimulong Plus Plexus Catheter K043130, K033018 2. Pajunks Plexolong Sets K042979, K023218, K013041 3. Pajunk Sprotte and various Anesthesia conduction cannulas K040965, K911202, K911260, K911221 4. BBrauns Espocan K932400 (including BBrauns Perifix K813186) ' Regulatory Class I CAZ, Kit, Condu… | 2004 |
| * | K911202 | Atraumatic Standard Sprotte NeedleSummary page 1…Stimulong Plus Plexus Catheter K043130, K033018 2. Pajunks Plexolong Sets K042979, K023218, K013041 3. Pajunk Sprotte and various Anesthesia conduction cannulas K040965, K911202, K911260, K911221 4. BBrauns Espocan K932400 (including BBrauns Perifix K813186) ' Regulatory Class I CAZ, Kit, Conduction Ane… | 1992 |
| * | K911260 | Atraumatic Standard Sprotte NeedleSummary page 1…Plus Plexus Catheter K043130, K033018 2. Pajunks Plexolong Sets K042979, K023218, K013041 3. Pajunk Sprotte and various Anesthesia conduction cannulas K040965, K911202, K911260, K911221 4. BBrauns Espocan K932400 (including BBrauns Perifix K813186) ' Regulatory Class I CAZ, Kit, Conduction Anesthesia… | 1991 |
| * | K911221 | Atraumatic Special Sprotte NeedleSummary page 1…xus Catheter K043130, K033018 2. Pajunks Plexolong Sets K042979, K023218, K013041 3. Pajunk Sprotte and various Anesthesia conduction cannulas K040965, K911202, K911260, K911221 4. BBrauns Espocan K932400 (including BBrauns Perifix K813186) ' Regulatory Class I CAZ, Kit, Conduction Anesthesia PMN-510(k… | 1992 |
| * | K932400 | Espocan Combined Spinal/Epidural Needle Set & TraySummary page 1…8 2. Pajunks Plexolong Sets K042979, K023218, K013041 3. Pajunk Sprotte and various Anesthesia conduction cannulas K040965, K911202, K911260, K911221 4. BBrauns Espocan K932400 (including BBrauns Perifix K813186) ' Regulatory Class I CAZ, Kit, Conduction Anesthesia PMN-510(k)-EpiSpin-CQ.doc PMN cQ - O… | 1993 |
| * | K813186 | Perfix Set for Epidural Anesthesia W/TuoSummary page 1…, K023218, K013041 3. Pajunk Sprotte and various Anesthesia conduction cannulas K040965, K911202, K911260, K911221 4. BBrauns Espocan K932400 (including BBrauns Perifix K813186) ' Regulatory Class I CAZ, Kit, Conduction Anesthesia PMN-510(k)-EpiSpin-CQ.doc PMN cQ - O CQ 2006-02-06 ND N === Page 2 ==… | 1981 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082183 | Pajunk's Generic Convenience Tray for Regional Anesthesia: CSF | 2008 | 0 |
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 · Direct predicate · ◆ in the 1992 ancestors bar of FIG. 11 Class I recall
- K911260Atraumatic Standard Sprotte NeedlePajunk GmbH · 1991 · Direct predicate · ◆ 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 22 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 5 of the 22 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.
- 2 other devices also cite its predicate K043130.
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 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 Fixolong is an adhesive disk with catheter clips and flat filter attachment point on top. It is employed for fixing the catheter during long term…
Read the full statement (316 words)
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 Fixolong is an adhesive disk with catheter clips and flat filter attachment point on top. It is employed for fixing the catheter during long term anesthesia conduction.
The adhesive is hypo-allergenic and prevents accidental removal of epidural catheter. The catheter fastening clips allows stabilization of epidural catheter and prevents accidental movement. On the top there is an attachment site for flat filter to protect fixation
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.
The Pajunk EpiSpin anesthesia conduction kit is indicated for administration of regional Combined Spinal-Epidural (CSE) anesthesia. The anesthesia conduction needle is intended for transient delivery of anesthetics to the spinal and epidural space, as well as catheter placement into 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 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).
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/K060563 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060563: Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060563
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