510(k) · Cleared
ClearedContiplex FX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · CAZ Anesthesia Conduction Kit
Cleared on Jan 24, 2012 as substantially equivalent to K090995 (B.Braun Medical, Inc., 2009) after a 102-day review. Its family tree reaches back 6 generations to 1984. 1 of the 16 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Jan 24, 2012
- Review
- 102 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K840287 (1984). 12 ancestors in all, the oldest K801912 (1980). 3 later devices descend from it, 2 citing it directly. 1 of the 16 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK840287 Brachial Plexus Anesthesia TrayBurron Medical Products, Inc. · 1984
- 5 generations backK013041 Plexolong SetsPajunk GmbH · 2002
- 4 generations backK023218 Modification to Plexolong SetsPajunk GmbH · 2003
- 3 generations backK033018 Stimulong Plus Catheter Set Model, VariousPajunk GmbH · 2004
- 2 generations backK063282 Contiplex Stim Continuous Nerve Block SetB.Braun Medical, Inc. · 2007
- 1 generation backK090995 B. Braun Contiplex Continuous Nerve Block SetB.Braun Medical, Inc. · 2009
- This deviceK113059 Contiplex FXB.Braun Medical, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK133632 Perican UltraB.Braun Medical, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK231242 Perifix FX Catheter; Contiplex FX CatheterB.Braun Medical, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK150266 Remington Medical Inc. Tuohy Epidural NeedlesRemington Medical, Inc. · 2015
Class I recalls in this family
- K801912 Arrow Positive Placement Con/Epidural an5 generations back · 1980
Most influential descendants
Showing 3 of 3 · See all- K133632Perican UltraB.Braun Medical, Inc. · 2014 · cites it directly1descendant
- K231242Perifix FX Catheter; Contiplex FX CatheterB.Braun Medical, Inc. · 2023 · cites it directly0descendants
- K150266Remington Medical Inc. Tuohy Epidural NeedlesRemington Medical, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K840287 | Brachial Plexus Anesthesia Tray | Burron Medical Products, Inc. | 1984 | — |
| −5 | K013041 | Plexolong Sets | Pajunk GmbH | 2002 | — |
| −4 | K023218 | Modification to Plexolong Sets | Pajunk GmbH | 2003 | — |
| −3 | K033018 | Stimulong Plus Catheter Set Model, Various | Pajunk GmbH | 2004 | — |
| −2 | K063282 | Contiplex Stim Continuous Nerve Block Set | B.Braun Medical, Inc. | 2007 | — |
| −1 | K090995 | B. Braun Contiplex Continuous Nerve Block Set | B.Braun Medical, Inc. | 2009 | — |
| 0 (this device) | K113059 | Contiplex FX | B.Braun Medical, Inc. | 2012 | — |
| +1 | K133632 | Perican Ultra | B.Braun Medical, Inc. | 2014 | — |
| +1 | K231242 | Perifix FX Catheter; Contiplex FX Catheter | B.Braun Medical, Inc. | 2023 | — |
| +2 | K150266 | Remington Medical Inc. Tuohy Epidural Needles | Remington Medical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 1 |
| 1983 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2023 | 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.
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 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? (1)
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 |
|---|---|---|---|
| * | K090995 | B. Braun Contiplex Continuous Nerve Block SetSummary page 1…Class HI, Product Code CAZ, 868.5140 PREDICATE DEVICES: Contiplex® Continuous Nerve Block Set, Braun Medical Inc., K090995, Class 11, CAZ 868.5140. DESCRIPTION: The B. Braun Contiplex EX Continuous Nerve Block Set… | 2009 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 5 generations back · ◆ in the 1980 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 12 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K133632 (B.Braun Medical, Inc., 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K090995.
How does its category compare?
All CAZ devicesCAZ Anesthesia Conduction Kit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 B. Braun Contiplex@ FX Continuous Nerve Block Set is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management. The Contiplex EX catheter may remain indwelling for up to 72 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113059 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113059: Contiplex FX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113059
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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