510(k) · Cleared
ClearedPortex 24G Pediatric Epidural and Peripheral Block Anesthesia Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Portex, Inc. · CAZ Anesthesia Conduction Kit
Cleared on Mar 10, 2004 as substantially equivalent to K962696 (B.Braun Medical, Inc., 1997) and 3 other predicates after a 163-day review. Its family tree reaches back 2 generations to 1981. 2 later devices descend from it.
- Decided
- Mar 10, 2004
- Review
- 163 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K813186 (1981). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK813186 Perfix Set for Epidural Anesthesia W/TuoBurron Medical Products, Inc. · 1981
- 1 generation backK962696 Perifix Pediatric Epidural KitB.Braun Medical, Inc. · 1997 · Recalled
- This deviceK033080 Portex 24G Pediatric Epidural and Peripheral Block Anesthesia CatheterPortex, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK062902 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K813186 | Perfix Set for Epidural Anesthesia W/Tuo | Burron Medical Products, Inc. | 1981 | — |
| −1 | K962696 | Perifix Pediatric Epidural Kit | B.Braun Medical, Inc. | 1997 | 1 |
| 0 (this device) | K033080 | Portex 24G Pediatric Epidural and Peripheral Block Anesthesia Catheter | Portex, Inc. | 2004 | — |
| +1 | 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 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 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? (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 |
|---|---|---|---|
| * | K962696 | Perifix Pediatric Epidural KitSummary page 2…T, 73 BS0,21 CFR 868.5 120 ____ Bivonia LV PREDICATE DEVICE(S): Predicate I: The B. Braun Periflex Continuous Epidural Pediatric Tray, K962696. This is the main predicate device cited for catheter size, design characteristics and indication for use. Pre… | 1997 |
| * | K992471 | Sims Portex Epidural Catheter, 20G Model# 4910-16/17; 21G Model# 4910-18Summary page 2…e main predicate device cited for catheter size, design characteristics and indication for use. Predicate 2: Our current 16g and ISg Epidural Catheter kits, K992471. This predicate device is cited, in conjunction with Predicate I above. for materials, biocompatibility, sterilizatio… | 1999 |
| * | K924541 | Epidural MinipackSummary page 2…ited, in conjunction with Predicate I above. for materials, biocompatibility, sterilization and packaging. Predicate 3: Our 23g Pediatric Epidural Minipack, K924541. This predicate device is cited, in conjunction with Predicate I above for tensile strength and elongation. Pr… | 1993 |
| * | K935927 | Concord/Portex Epidural CathetersSummary page 2…edicate device is cited, in conjunction with Predicate I above for tensile strength and elongation. Predicate 4: Our 2lg High Durorneter Epidural; Catheter, K935927, This predicate, device is cited, in conjunction with Predicate 2 above for biocompatibi lity for the inik. DESCRIP… | 1994 |
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? (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 23 years and passes through 3 companies; a new generation was cleared every 15.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K062902 (PAJUNK GmbH Medizintechnologie, 2007) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K962696.
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 Portex ® 24g Pediatric Epidural and Peripheral Block Anesthesia Catheter is designed for use primarily in pediatric applications (children uider 12 years, infants and neonates) for continuous or intermittent regional anesthesia, e.g. epidural, caudal and peripheral blocks. The duration of use should not exceed 72 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033080 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033080: Portex 24G Pediatric Epidural and Peripheral Block Anesthesia Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033080
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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