510(k) · Cleared
ClearedPerifix Catheter and Contiplex Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · BSO Catheter, Conduction, Anesthetic
Cleared on Sep 30, 2004 as substantially equivalent to K951927 (Csen, Ltd., 1997) and 1 other predicate after a 17-day review. Its family tree reaches back 5 generations to 1990. 1 of the 24 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.
- Decided
- Sep 30, 2004
- Review
- 17 days
- Class
- Class II
- Product code
- BSO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K896422 (1990). 14 ancestors in all, the oldest K801912 (1980). 9 later devices descend from it, 6 citing it directly. 1 of the 24 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 4 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
- 3 generations backK982946 Painbuster Infusion KitI-Flow Corp. · 1998
- 2 generations backK984502 Nerve Block Infusion KitI-Flow Corp. · 1999
- 1 generation backK030830 B. Braun Nerve Block CatheterB.Braun Medical, Inc. · 2003
- This deviceK042488 Perifix Catheter and Contiplex CatheterB.Braun Medical, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK043500 Functional Anaesthetic Discography (Fad) System, Including Fad…Innospine, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 2 of its ownK061210 Functional Anaesthetic Discography (Fad) Catheter System, Model D01A…Kyphon, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK063071 Discyphor Catheter System, Model D01A; Discyphor Introducer Needle…Kyphon, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK153297 Perifix and Contiplex CatheterB.Braun Medical, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK150731 Medline Epidural CatheterMedline Industries, Inc. · 2016
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K801912 Arrow Positive Placement Con/Epidural an3 generations back · 1980
Most influential descendants
Showing 5 of 9 · See all- K043500Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad…Innospine, Inc. · 2005 · cites it directly3descendants
- K061210Functional Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer…Kyphon, Inc. · 2006 · 2 generations on2descendants
- K063071Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01BKyphon, Inc. · 2007 · 2 generations on1descendant
- K153297Perifix and Contiplex CatheterB.Braun Medical, Inc. · 2016 · cites it directly0descendants
- K150731Medline Epidural CatheterMedline Industries, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| −4 | K980558 | Painbuster Infusion System | I-Flow Corp. | 1998 | — |
| −3 | K982946 | Painbuster Infusion Kit | I-Flow Corp. | 1998 | — |
| −2 | K984502 | Nerve Block Infusion Kit | I-Flow Corp. | 1999 | — |
| −1 | K030830 | B. Braun Nerve Block Catheter | B.Braun Medical, Inc. | 2003 | — |
| 0 (this device) | K042488 | Perifix Catheter and Contiplex Catheter | B.Braun Medical, Inc. | 2004 | — |
| +1 | K043500 | Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit… | Innospine, Inc. | 2005 | 1 |
| +2 | K061210 | Functional Anaesthetic Discography (Fad) Catheter System, Model D01A… | Kyphon, Inc. | 2006 | — |
| +2 | K063071 | Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01B | Kyphon, Inc. | 2007 | — |
| +1 | K153297 | Perifix and Contiplex Catheter | B.Braun Medical, Inc. | 2016 | — |
| +1 | K150731 | Medline Epidural Catheter | Medline Industries, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 1 |
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 2 | 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 BSO device
- #1 K241410 EDEN ControlCathscore 9.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K951927 | Combined End-Multiple Lateral Holes Epidural Catheter (Cemlh Epidural Catheter)Summary page 1…21 CFR Part 868.5120, Product Code BSO PREDICATE DEVICE: Csen Ltd, Combined End-Multiple Lateral Hole Epidural Catheter, K95 1927 B. Braun Medical Inc., B. Braun Nerve Block Catheter, K030380 DESCRIPTION:… | 1997 |
| * | K030830 | B. Braun Nerve Block CatheterSummary page 2…n Regional Anesthesia catheter is similar in size, application, performance and sterilization methods to the B. Braun Nerve Block Catheter (K030830). Both of these catheters are available in open and closed tip configurations and are provided in t… | 2003 |
What descends from it? (9)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043500 | Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad… | 2005 | 3 |
| K153297 | Perifix and Contiplex Catheter | 2016 | 0 |
| K150731 | Medline Epidural Catheter | 2016 | 0 |
| K102594 | IO-Flex Catheter | 2011 | 0 |
| K090884 | Perifix One Pediatric Catheter, 20 GA. & 24 GA. | 2009 | 0 |
| K050557 | Amt Nanocath | 2005 | 0 |
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 · 3 generations back · ◆ in the 1980 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 14 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K043500 (Innospine, Inc., 2005) has gone furthest, with 3 descendants of its own.
How does its category compare?
All BSO devicesBSO Catheter, Conduction, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BSO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSO
205in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSO
2so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BSO
139in 2025
MAUDE reports naming product code BSO, 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 | 2 | — | 0 | 18 |
| 2008 | 3 | 155 | 0 | 14 |
| 2009 | 1 | — | 1 | 71 |
| 2010 | 1 | — | 0 | 57 |
| 2011 | 4 | 109 | 0 | 31 |
| 2012 | 0 | — | 0 | 52 |
| 2013 | 1 | — | 0 | 73 |
| 2014 | 2 | — | 0 | 45 |
| 2015 | 1 | — | 0 | 43 |
| 2016 | 5 | 281 | 0 | 71 |
| 2017 | 3 | 205 | 0 | 38 |
| 2018 | 2 | — | 0 | 80 |
| 2019 | 2 | — | 0 | 779 |
| 2020 | 2 | — | 0 | 159 |
| 2021 | 0 | — | 0 | 146 |
| 2022 | 0 | — | 0 | 135 |
| 2023 | 2 | — | 0 | 79 |
| 2024 | 0 | — | 0 | 98 |
| 2025 | 1 | — | 0 | 139 |
| 2026 | 0 | — | 2 (1) | — |
What is it indicated for?
The B. Braun Regional Anesthesia Catheter is a device intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics and analgesics in the epidural space or near a nerve for regional anesthesia and pain management during the pre-operative, perioperative and postoperative periods associated with general and orthopedic surgery as well as labor and delivery. Routes of administration include epidural and perineural (peripheral nerve block).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042488 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042488: Perifix Catheter and Contiplex Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042488
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