510(k) Report

510(k) · Cleared

Cleared

Contiplex Stim Continuous Nerve Block Set

K063282510(k) TraditionalCleared Jun 20, 2007232-day reviewClass II21 CFR 868.5140

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

B.Braun Medical, Inc. · CAZ Anesthesia Conduction Kit

Cleared on Jun 20, 2007 as substantially equivalent to K030937 (Arrow International, Inc., 2003) and 1 other predicate after a 232-day review. Its family tree reaches back 4 generations to 1984. 1 of the 24 devices in its family, counting itself, has a Class I recall. 13 later devices descend from it.

Decided
Jun 20, 2007
Review
232 days
Class
Class II
Product code
CAZ
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K840287 (1984). 10 ancestors in all, the oldest K801912 (1980). 13 later devices descend from it, 1 citing it directly. 1 of the 24 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2002: 1 other ancestor2000: 2 other ancestors1983: 1 other ancestor1980: 1 other ancestor, 1 with a Class I recall12009: 1 descendant cleared2010: 1 descendant cleared2012: 2 descendants cleared2020: 2 descendants cleared2018: 1 descendant cleared2023: 1 descendant cleared2014: 1 descendant cleared2016: 1 descendant cleared2015: 1 descendant cleared2022: 1 descendant cleared2024: 1 descendant clearedK840287 · Brachial Plexus Anesthesia Tray · Burron Medical Products, Inc. · 1984K013041 · Plexolong Sets · Pajunk GmbH · 2002K023218 · Modification to Plexolong Sets · Pajunk GmbH · 2003K033018 · Stimulong Plus Catheter Set Model, Various · Pajunk GmbH · 200419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors3 generations back: 2 other ancestors, 1 with a Class I recall1 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 5 descendants4 generations forward: 4 descendants5 generations forward: 1 descendant K033018 · Stimulong Plus Catheter Set Model, Various · Pajunk GmbH · 2004K023218 · Modification to Plexolong Sets · Pajunk GmbH · 2003K013041 · Plexolong Sets · Pajunk GmbH · 2002K840287 · Brachial Plexus Anesthesia Tray · Burron Medical Products, Inc. · 19840+5
  1. Root · 4 generations backK840287 Brachial Plexus Anesthesia TrayBurron Medical Products, Inc. · 1984
  2. 3 generations backK013041 Plexolong SetsPajunk GmbH · 2002
  3. 2 generations backK023218 Modification to Plexolong SetsPajunk GmbH · 2003
  4. 1 generation backK033018 Stimulong Plus Catheter Set Model, VariousPajunk GmbH · 2004
  5. This deviceK063282 Contiplex Stim Continuous Nerve Block SetB.Braun Medical, Inc. · 2007
  6. Descendant · cites it directly · 12 of its ownK090995 B. Braun Contiplex Continuous Nerve Block SetB.Braun Medical, Inc. · 2009
  7. Descendant · 2 generations on · 7 of its ownK100241 Contiplex D Continuous Nerve Block Set, Model 331687, 331686…B.Braun Medical, Inc. · 2010
  8. Descendant · 2 generations on · 3 of its ownK113059 Contiplex FXB.Braun Medical, Inc. · 2012
  9. Descendant · 3 generations on · 2 of its ownK173763 iovera systemMyoscience, Inc. · 2018
  10. Descendant · 3 generations on · 2 of its ownK121846 Contiplex C Continuous Peripheral Nerve Block NeedleB.Braun Medical, Inc. · 2012

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12012: 22014: 12015: 12016: 12018: 12020: 22022: 12023: 12024: 1
2009high 2 (2012) · low 0 (2011)2026

Class I recalls in this family

Most influential descendants

Showing 5 of 13 · See all
  • K090995B. Braun Contiplex Continuous Nerve Block SetB.Braun Medical, Inc. · 2009 · cites it directly12descendants
  • K100241Contiplex D Continuous Nerve Block Set, Model 331687, 331686, 331685, 331680B.Braun Medical, Inc. · 2010 · 2 generations on7descendants
  • K113059Contiplex FXB.Braun Medical, Inc. · 2012 · 2 generations on3descendants
  • K173763iovera systemMyoscience, Inc. · 2018 · 3 generations on2descendants
  • K121846Contiplex C Continuous Peripheral Nerve Block NeedleB.Braun Medical, Inc. · 2012 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K840287Brachial Plexus Anesthesia TrayBurron Medical Products, Inc.1984—
−3K013041Plexolong SetsPajunk GmbH2002—
−2K023218Modification to Plexolong SetsPajunk GmbH2003—
−1K033018Stimulong Plus Catheter Set Model, VariousPajunk GmbH2004—
0 (this device)K063282Contiplex Stim Continuous Nerve Block SetB.Braun Medical, Inc.2007—
+1K090995B. Braun Contiplex Continuous Nerve Block SetB.Braun Medical, Inc.2009—
+2K100241Contiplex D Continuous Nerve Block Set, Model 331687, 331686, 331685, 331680B.Braun Medical, Inc.2010—
+2K113059Contiplex FXB.Braun Medical, Inc.2012—
+3K173763iovera systemMyoscience, Inc.2018—
+3K121846Contiplex C Continuous Peripheral Nerve Block NeedleB.Braun Medical, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198011
198310
200020
200210
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201220
201410
201510
201610
201810
202020
202210
202310
202410
FIG. 1 — Lineage of K063282, 1984–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261372 Profoject™ LOR Syringescore 12.4 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K030937Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060, AB-02090, AB-02030-PK…
Summary page 1
…R 868.5140 - Anesthetic Conduction Kit Class LI, Product Code CAZ PREDICATE DEVICES: Arrow StimuCath Continuous Nerve Block Set 5 10(k) K030937 PAJUNK QmbH Stimulong Plus Catheter Sets 5 10(k) K033018 DESCRfl'TION: The CONTIPLEX* Stimt Continuou…
Arrow International, Inc.20031
*K033018Stimulong Plus Catheter Set Model, Various
Summary page 1
…Code CAZ PREDICATE DEVICES: Arrow StimuCath Continuous Nerve Block Set 5 10(k) K030937 PAJUNK QmbH Stimulong Plus Catheter Sets 5 10(k) K033018 DESCRfl'TION: The CONTIPLEX* Stimt Continuous Nerve Block Set is a kit that contains a stimulating cat…
Pajunk GmbH2004—

Also cleared against K030937: 3 other devices →

What descends from it? (13)

See all 13

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K090995B. Braun Contiplex Continuous Nerve Block SetB.Braun Medical, Inc.200912

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 23 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
  • 3 of the 10 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K090995 (B.Braun Medical, Inc., 2009) has gone furthest, with 12 descendants of its own.
  • 3 other devices also cite its predicate K030937.

How does its category compare?

All CAZ devices

CAZ 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

2007: 42008: 42009: 22010: 22011: 12012: 92015: 12016: 22019: 12020: 12021: 12022: 12023: 12026 (partial year): 1
2007high 9 (2012) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAZ

108in 2012

2007: 172 days median2008: 99 days median2012: 108 days median
2007high 172 (2007) · low 99 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CAZ

1in 2024

2009: 292010: 82011: 22013: 122014: 22015: 12016: 12024: 12026 (partial year): 12, 11 Class I
2007high 29 (2009) · low 0 (2007)2026

Class I (11 since 2007) Class II/III not classified

Adverse event reports per year · CAZ

137in 2025

2007: 812008: 802009: 1342010: 1392011: 1872012: 1872013: 2762014: 2512015: 2352016: 3722017: 3532018: 4482019: 4722020: 2742021: 1652022: 2702023: 602024: 1652025: 137
2007high 472 (2019) · low 60 (2023)2025

MAUDE reports naming product code CAZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074172081
2008499080
20092—29134
20102—8139
20111—2187
201291080187
20130—12276
20140—2251
20151—1235
20162—1372
20170—0353
20180—0448
20191—0472
20201—0274
20211—0165
20221—0270
20231—060
20240—1165
20250—0137
20261—12 (11)—

What is it indicated for?

The CONTIPLEX® Stim Continuous Nerve Block Set is intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics and analgesics near a nerve for regional anesthesia and/or pain management during the pre-operative, perioperative and post-operative periods associated with general and orthopedic surgery. Routes of administration are perineural (peripheral nerve block). The CONTIPLEX® catheter can be used for up to 72 hours.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K063282: Contiplex Stim Continuous Nerve Block Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063282

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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