510(k) · Cleared
ClearedPajunks Epilong Set Pediatric
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 7, 2007 as substantially equivalent to K060311 (PAJUNK GmbH Medizintechnologie, 2006) and 3 other predicates after a 253-day review. Its family tree reaches back 3 generations to 1981. 1 later device descends from it.
- Decided
- Jun 7, 2007
- Review
- 253 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K813186 (1981). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK813186 Perfix Set for Epidural Anesthesia W/TuoBurron Medical Products, Inc. · 1981
- 2 generations backK962696 Perifix Pediatric Epidural KitB.Braun Medical, Inc. · 1997 · Recalled
- 1 generation backK033080 Portex 24G Pediatric Epidural and Peripheral Block Anesthesia CatheterPortex, Inc. · 2004
- This deviceK062902 Pajunks Epilong Set PediatricPAJUNK GmbH Medizintechnologie · 2007
- Descendant · cites it directly · 0 of its ownK090884 Perifix One Pediatric Catheter, 20 GA. & 24 GA.B.Braun Medical, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K090884Perifix One Pediatric Catheter, 20 GA. & 24 GA.B.Braun Medical, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K813186 | Perfix Set for Epidural Anesthesia W/Tuo | Burron Medical Products, Inc. | 1981 | — |
| −2 | K962696 | Perifix Pediatric Epidural Kit | B.Braun Medical, Inc. | 1997 | 1 |
| −1 | K033080 | Portex 24G Pediatric Epidural and Peripheral Block Anesthesia Catheter | Portex, Inc. | 2004 | — |
| 0 (this device) | K062902 | Pajunks Epilong Set Pediatric | PAJUNK GmbH Medizintechnologie | 2007 | — |
| +1 | K090884 | Perifix One Pediatric Catheter, 20 GA. & 24 GA. | B.Braun Medical, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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…ion: Proposed Product CAZ, Kit, Conduction Anesthesia Classification Code: Panel: Anesthesiology Predicate Devices: 1. Pajunks EpiLong Set K060311 2. Portex Pediatric Epidural and Peripheral Block Anesthesia Catheter K… | 2006 |
| * | K033080 | Portex 24G Pediatric Epidural and Peripheral Block Anesthesia CatheterSummary page 1…ces: 1. Pajunks EpiLong Set K060311 2. Portex Pediatric Epidural and Peripheral Block Anesthesia Catheter K033080 3. MEDDEVICE's BIO-MATE pediatric epidural catheter K901129 4. BBrauns PERI… | 2004 |
| * | K901129 | Bio-Mate (TM) Pediatric Epidural CatheterSummary page 1…c Epidural and Peripheral Block Anesthesia Catheter K033080 3. MEDDEVICE's BIO-MATE pediatric epidural catheter K901129 4. BBrauns PERIFIX pediatric epidural kit K962696 -008- AI-K… | 1990 |
| * | K962696 | Perifix Pediatric Epidural KitSummary page 1…heter K033080 3. MEDDEVICE's BIO-MATE pediatric epidural catheter K901129 4. BBrauns PERIFIX pediatric epidural kit K962696 -008- AI-K062902 Al-Ill-mod.doc Pajunks EpiL… | 1997 |
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 |
|---|---|---|---|
| K090884 | Perifix One Pediatric Catheter, 20 GA. & 24 GA. | 2009 | 0 |
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?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K090884 (B.Braun Medical, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 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. 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 EpiLong Sets Pediatric are intended for delivery of continuous conduction of epidural anesthesia. The catheter has to be removed or replaced after 72 hours. They are to be used with pediatric patient population. The Pajunk EpiLong Sets Pediatric acc. Marhover are intended for delivery of continuous conduction of epidural anesthesia. The Marhover-Set contains a NanoLine coated cannula. The catheter has to be removed or replaced after 72 hours.…
Read the full statement (193 words)
The Pajunk EpiLong Sets Pediatric are intended for delivery of continuous conduction of epidural anesthesia. The catheter has to be removed or replaced after 72 hours.
They are to be used with pediatric patient population.
The Pajunk EpiLong Sets Pediatric acc. Marhover are intended for delivery of continuous conduction of epidural anesthesia. The Marhover-Set contains a NanoLine coated cannula. The catheter has to be removed or replaced after 72 hours.
They are to be used with pediatric patient population.
The Pajunk pediatric epidural catheter is placed in the epidural space to facilitate a longer anesthetic effect.
It is intended for use with pediatric patients.
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. It has to be removed or replaced after 72 hours.
Pajunks pediatric epidural needles are anesthesia conduction needles employed to identify and to access epidural space.
It is intended for use with pediatric patients.
After epidural space is accessed and the catheter is inserted the anesthesia conduction needle has to be withdrawn from the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062902 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062902: Pajunks Epilong Set Pediatric.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062902
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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