510(k) · Cleared
ClearedSolo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solo-Dex, Inc. · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Jan 22, 2016 as substantially equivalent to K121846 (B.Braun Medical, Inc., 2012) after a 276-day review. Its family tree reaches back 8 generations to 1984. 1 of the 16 devices in its family, counting itself, has a Class I recall.
- Decided
- Jan 22, 2016
- Review
- 276 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K840287 (1984). 15 ancestors in all, the oldest K801912 (1980). No later device cites it as a predicate yet. 1 of the 16 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK840287 Brachial Plexus Anesthesia TrayBurron Medical Products, Inc. · 1984
- 7 generations backK013041 Plexolong SetsPajunk GmbH · 2002
- 6 generations backK023218 Modification to Plexolong SetsPajunk GmbH · 2003
- 5 generations backK033018 Stimulong Plus Catheter Set Model, VariousPajunk GmbH · 2004
- 4 generations backK063282 Contiplex Stim Continuous Nerve Block SetB.Braun Medical, Inc. · 2007
- 3 generations backK090995 B. Braun Contiplex Continuous Nerve Block SetB.Braun Medical, Inc. · 2009
- 2 generations backK100241 Contiplex D Continuous Nerve Block Set, Model 331687, 331686…B.Braun Medical, Inc. · 2010
- 1 generation backK121846 Contiplex C Continuous Peripheral Nerve Block NeedleB.Braun Medical, Inc. · 2012
- This deviceK151072 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 an7 generations back · 1980
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K840287 | Brachial Plexus Anesthesia Tray | Burron Medical Products, Inc. | 1984 | — |
| −7 | K013041 | Plexolong Sets | Pajunk GmbH | 2002 | — |
| −6 | K023218 | Modification to Plexolong Sets | Pajunk GmbH | 2003 | — |
| −5 | K033018 | Stimulong Plus Catheter Set Model, Various | Pajunk GmbH | 2004 | — |
| −4 | K063282 | Contiplex Stim Continuous Nerve Block Set | B.Braun Medical, Inc. | 2007 | — |
| −3 | K090995 | B. Braun Contiplex Continuous Nerve Block Set | B.Braun Medical, Inc. | 2009 | — |
| −2 | K100241 | Contiplex D Continuous Nerve Block Set, Model 331687, 331686, 331685, 331680 | B.Braun Medical, Inc. | 2010 | — |
| −1 | K121846 | Contiplex C Continuous Peripheral Nerve Block Needle | B.Braun Medical, Inc. | 2012 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K121846 | Contiplex C Continuous Peripheral Nerve Block NeedleSummary page 4…y Regulatory Class: Class II Product Code: BSP III. PREDICATE DEVICE: Complex® C Continuous Peripheral Nerve Block Needle (K121846) IV. DEVICE DESCRIPTION: Solo‐Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit is a needle comprised of a… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 7 generations back · ◆ in the 1980 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 3 of the 15 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K121846.
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. 2016, 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 Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit is intended for use in regional anesthesia and pain therapy to locate peripheral nerves by transferring electrical impulses from a nerve stimulator, or to be seen by ultrasound visualization of the device. The needle is used to inject and facilitate the continuous and/or intermittent administration of local anesthetics or analgesics to the targeted nerve bundle in surgical…
Read the full statement (139 words)
The Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit is intended for use in regional anesthesia and pain therapy to locate peripheral nerves by transferring electrical impulses from a nerve stimulator, or to be seen by ultrasound visualization of the device. The needle is used to inject and facilitate the continuous and/or intermittent administration of local anesthetics or analgesics to the targeted nerve bundle in surgical procedures.
In packaged set configurations, the Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit, consisting of the peripheral nerve block needle, catheter, and related peripheral nerve block procedural accessories, is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management during pre-operative, peri-operative and post-operative periods associated with surgical procedures. The catheter may remain indwelling for up to 72 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151072 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151072: Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151072
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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