510(k) · Cleared
ClearedContiplex C Continuous Peripheral Nerve Block Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Nov 20, 2012 as substantially equivalent to K100241 (B.Braun Medical, Inc., 2010) after a 148-day review. Its family tree reaches back 7 generations to 1984. 1 of the 17 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Nov 20, 2012
- Review
- 148 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K840287 (1984). 14 ancestors in all, the oldest K801912 (1980). 2 later devices descend from it, 2 citing it directly. 1 of the 17 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK840287 Brachial Plexus Anesthesia TrayBurron Medical Products, Inc. · 1984
- 6 generations backK013041 Plexolong SetsPajunk GmbH · 2002
- 5 generations backK023218 Modification to Plexolong SetsPajunk GmbH · 2003
- 4 generations backK033018 Stimulong Plus Catheter Set Model, VariousPajunk GmbH · 2004
- 3 generations backK063282 Contiplex Stim Continuous Nerve Block SetB.Braun Medical, Inc. · 2007
- 2 generations backK090995 B. Braun Contiplex Continuous Nerve Block SetB.Braun Medical, Inc. · 2009
- 1 generation backK100241 Contiplex D Continuous Nerve Block Set, Model 331687, 331686…B.Braun Medical, Inc. · 2010
- This deviceK121846 Contiplex C Continuous Peripheral Nerve Block NeedleB.Braun Medical, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK191290 Ancora Nerve Block Catheter SetAncora Medical Technology · 2020
- Descendant · cites it directly · 0 of its ownK151072 Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and…Solo-Dex, Inc. · 2016
Class I recalls in this family
- K801912 Arrow Positive Placement Con/Epidural an6 generations back · 1980
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 |
|---|---|---|---|---|---|
| −7 | K840287 | Brachial Plexus Anesthesia Tray | Burron Medical Products, Inc. | 1984 | — |
| −6 | K013041 | Plexolong Sets | Pajunk GmbH | 2002 | — |
| −5 | K023218 | Modification to Plexolong Sets | Pajunk GmbH | 2003 | — |
| −4 | K033018 | Stimulong Plus Catheter Set Model, Various | Pajunk GmbH | 2004 | — |
| −3 | K063282 | Contiplex Stim Continuous Nerve Block Set | B.Braun Medical, Inc. | 2007 | — |
| −2 | K090995 | B. Braun Contiplex Continuous Nerve Block Set | B.Braun Medical, Inc. | 2009 | — |
| −1 | K100241 | Contiplex D Continuous Nerve Block Set, Model 331687, 331686, 331685, 331680 | B.Braun Medical, Inc. | 2010 | — |
| 0 (this device) | K121846 | Contiplex C Continuous Peripheral Nerve Block Needle | B.Braun Medical, Inc. | 2012 | — |
| +1 | K191290 | Ancora Nerve Block Catheter Set | Ancora Medical Technology | 2020 | — |
| +1 | K151072 | Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit | Solo-Dex, Inc. | 2016 | — |
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 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 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 BSP device
- #1 K241954 SonoBlock; SonoBlock IIscore 11.0 · 1 generation · 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 |
|---|---|---|---|
| * | K100241 | Contiplex D Continuous Nerve Block Set, Model 331687, 331686, 331685, 331680Summary page 1…ulated Needle, Stimuplex D Insulated Needle B. Braun Medical, Inc., Contiplex D Continuous Nerve Block Set, K100241, Class 11, BSP, 868.5150 DESCRIPTION: The Contiplex C Continuous Peripheral Nerve Block Needle is a… | 2010 |
| * | — | Stimuplex D Insulated Needle Named without a submission number |
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? (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 · 6 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 2.2 years on median.
- 3 of the 14 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K191290 (Ancora Medical Technology, 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K100241.
How does its category compare?
All BSP devicesBSP Needle, Conduction, Anesthetic (W/Wo Introducer): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · BSP
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSP
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSP
1in 2020
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BSP
86in 2025
MAUDE reports naming product code BSP, 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 | 3 | 189 | 0 | 26 |
| 2008 | 8 | 127 | 0 | 24 |
| 2009 | 5 | 97 | 0 | 30 |
| 2010 | 3 | 79 | 0 | 49 |
| 2011 | 3 | 114 | 0 | 33 |
| 2012 | 3 | 148 | 0 | 20 |
| 2013 | 2 | — | 0 | 32 |
| 2014 | 2 | — | 0 | 41 |
| 2015 | 2 | — | 0 | 38 |
| 2016 | 6 | 268 | 1 | 152 |
| 2017 | 4 | 186 | 0 | 34 |
| 2018 | 8 | 241 | 0 | 69 |
| 2019 | 2 | — | 1 | 86 |
| 2020 | 3 | 269 | 1 | 78 |
| 2021 | 3 | 265 | 0 | 52 |
| 2022 | 2 | — | 0 | 84 |
| 2023 | 0 | — | 0 | 75 |
| 2024 | 3 | 70 | 0 | 66 |
| 2025 | 4 | 170 | 0 | 86 |
| 2026 | 0 | — | 1 (1) | — |
What is it indicated for?
The Contiplex C Continuous Peripheral Nerve Block Needle is intended for use in regional anesthesia and pain therapy to locate peripheral nerves by transferring electrical impulses from a nerve stimulator or through ultrasound visualization of the device. The needle is used to inject and facilitate the continuous administration of local anesthetics or analgesics to the targeted nerve bundle for general and orthopedic surgery. The Contiplex C Continuous…
Read the full statement (128 words)
The Contiplex C Continuous Peripheral Nerve Block Needle is intended for use in regional anesthesia and pain therapy to locate peripheral nerves by transferring electrical impulses from a nerve stimulator or through ultrasound visualization of the device. The needle is used to inject and facilitate the continuous administration of local anesthetics or analgesics to the targeted nerve bundle for general and orthopedic surgery.
The Contiplex C Continuous Peripheral Nerve Block Set, consisting of the peripheral nerve block needle, catheter, and related peripheral nerve block procedural accessories, is intended to provide continuous and/or intermittent inflision of local anesthetics and analgesics for peripheral plexus anesthesia and pain management during pre-operative, perioperative and post-operative periods associated with general and orthopedic surgery. The catheter may remain indwelling for up to 72 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121846 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121846: Contiplex C Continuous Peripheral Nerve Block Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121846
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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