510(k) · Cleared
ClearedB. Braun Nerve Block Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · MEB Pump, Infusion, Elastomeric
Cleared on Jul 15, 2003 as substantially equivalent to K971233 (B.Braun Medical, Inc., 1997) and 3 other predicates after a 123-day review. Its family tree reaches back 4 generations to 1990. 1 of the 23 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it.
- Decided
- Jul 15, 2003
- Review
- 123 days
- Class
- Class II
- Product code
- MEB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K896422 (1990). 12 ancestors in all, the oldest K801912 (1980). 10 later devices descend from it, 1 citing it directly. 1 of the 23 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 3 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
- 2 generations backK982946 Painbuster Infusion KitI-Flow Corp. · 1998
- 1 generation backK984502 Nerve Block Infusion KitI-Flow Corp. · 1999
- This deviceK030830 B. Braun Nerve Block CatheterB.Braun Medical, Inc. · 2003
- Descendant · cites it directly · 9 of its ownK042488 Perifix Catheter and Contiplex CatheterB.Braun Medical, Inc. · 2004
- Descendant · 2 generations on · 3 of its ownK043500 Functional Anaesthetic Discography (Fad) System, Including Fad…Innospine, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 2 of its ownK061210 Functional Anaesthetic Discography (Fad) Catheter System, Model D01A…Kyphon, Inc. · 2006
- Descendant · 3 generations on · 1 of its ownK063071 Discyphor Catheter System, Model D01A; Discyphor Introducer Needle…Kyphon, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK153297 Perifix and Contiplex CatheterB.Braun Medical, Inc. · 2016
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K801912 Arrow Positive Placement Con/Epidural an2 generations back · 1980
Most influential descendants
Showing 5 of 10 · See all- K042488Perifix Catheter and Contiplex CatheterB.Braun Medical, Inc. · 2004 · cites it directly9descendants
- K043500Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad…Innospine, Inc. · 2005 · 2 generations on3descendants
- K061210Functional Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer…Kyphon, Inc. · 2006 · 3 generations on2descendants
- K063071Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01BKyphon, Inc. · 2007 · 3 generations on1descendant
- K153297Perifix and Contiplex CatheterB.Braun Medical, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| −3 | K980558 | Painbuster Infusion System | I-Flow Corp. | 1998 | — |
| −2 | K982946 | Painbuster Infusion Kit | I-Flow Corp. | 1998 | — |
| −1 | K984502 | Nerve Block Infusion Kit | I-Flow Corp. | 1999 | — |
| 0 (this device) | K030830 | B. Braun Nerve Block Catheter | B.Braun Medical, Inc. | 2003 | — |
| +1 | K042488 | Perifix Catheter and Contiplex Catheter | B.Braun Medical, Inc. | 2004 | — |
| +2 | K043500 | Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit… | Innospine, Inc. | 2005 | 1 |
| +3 | K061210 | Functional Anaesthetic Discography (Fad) Catheter System, Model D01A… | Kyphon, Inc. | 2006 | — |
| +3 | K063071 | Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01B | Kyphon, Inc. | 2007 | — |
| +2 | K153297 | Perifix and Contiplex Catheter | B.Braun Medical, 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 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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 MEB device
- #1 K250234 SMARTeZ™ Elastomeric Infusion Pump (RS series)score 14.5 · 12 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 |
|---|---|---|---|
| * | K971233 | Soft Tip Epidural Catheter KitSummary page 1…CLASSIFICATION: 21 CFR 0 880.5725 (Elastomeric Infusion Pump) PREDICATE DEVICE: B. Braun Medical Inc. Soft Tip Epidural Catheter Kit (K971233) B. Braun Medical Inc. PerifixB Set for Epidural Anesthesia with… | 1997 |
| * | K813186 | Perfix Set for Epidural Anesthesia W/TuoSummary page 1…33) B. Braun Medical Inc. PerifixB Set for Epidural Anesthesia with Tuohy Needle and Catheter (K8 13186) I-Flow Corporation Nerve Block Infusion Kit (K984502) I-Flow… | 1981 |
| * | K984502 | Nerve Block Infusion KitSummary page 1…sthesia with Tuohy Needle and Catheter (K8 13186) I-Flow Corporation Nerve Block Infusion Kit (K984502) I-Flow Corporation Intra Op Catheter (K99 1543) DESCRIPTION: The B. Brau… | 1999 |
| * | K991543 | Intraop CatheterSummary page 1…K8 13186) I-Flow Corporation Nerve Block Infusion Kit (K984502) I-Flow Corporation Intra Op Catheter (K99 1543) DESCRIPTION: The B. Braun Nerve Block Catheter consists of polyamide tubing… | 1999 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042488 | Perifix Catheter and Contiplex Catheter | 2004 | 9 |
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 · 2 generations back · ◆ in the 1980 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- 2 of the 12 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K042488 (B.Braun Medical, Inc., 2004) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K971233.
How does its category compare?
All MEB devicesMEB Pump, Infusion, Elastomeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEB
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MEB
42in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEB
17in 2018
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · MEB
1,408in 2025
MAUDE reports naming product code MEB, 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 | 5 | 42 | 1 | 110 |
| 2008 | 2 | — | 3 | 444 |
| 2009 | 1 | — | 48 | 798 |
| 2010 | 0 | — | 2 | 1,827 |
| 2011 | 0 | — | 8 (1) | 2,265 |
| 2012 | 0 | — | 0 | 1,976 |
| 2013 | 1 | — | 2 (1) | 1,956 |
| 2014 | 1 | — | 0 | 2,695 |
| 2015 | 0 | — | 0 | 2,980 |
| 2016 | 1 | — | 0 | 2,147 |
| 2017 | 0 | — | 0 | 1,653 |
| 2018 | 0 | — | 17 | 1,473 |
| 2019 | 1 | — | 0 | 974 |
| 2020 | 0 | — | 0 | 2,732 |
| 2021 | 0 | — | 0 | 1,802 |
| 2022 | 0 | — | 0 | 1,288 |
| 2023 | 0 | — | 0 | 1,248 |
| 2024 | 2 | — | 0 | 1,424 |
| 2025 | 0 | — | 0 | 1,408 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The B. Braun Nerve Block Catheter is a device intended to provide, via percutaneous administration, continuous andor intermittent infusion of local anesthetics near a nerve for regional anesthesia and pain management during the pre-operative, perioperative and postoperative periods associated with general and orthopedic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030830 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030830: B. Braun Nerve Block Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030830
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