510(k) · Cleared
ClearedEchostim Facet Tip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Havel'S, Inc. · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Apr 25, 2007 as substantially equivalent to K000722 (Pajunk GmbH, 2000) and 1 other predicate after a 168-day review. Its family tree reaches back 2 generations to 1984. 11 later devices descend from it.
- Decided
- Apr 25, 2007
- Review
- 168 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K840287 (1984). 3 ancestors in all. 11 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK840287 Brachial Plexus Anesthesia TrayBurron Medical Products, Inc. · 1984
- 1 generation backK013041 Plexolong SetsPajunk GmbH · 2002
- This deviceK063380 Echostim Facet TipHavel'S, Inc. · 2007
- Descendant · cites it directly · 7 of its ownK100241 Contiplex D Continuous Nerve Block Set, Model 331687, 331686…B.Braun Medical, Inc. · 2010
- Descendant · 2 generations on · 2 of its ownK173763 iovera systemMyoscience, Inc. · 2018
- Descendant · 2 generations on · 2 of its ownK121846 Contiplex C Continuous Peripheral Nerve Block NeedleB.Braun Medical, Inc. · 2012
- Descendant · 3 generations on · 1 of its ownK220656 iovera SystemPacira Biosciences, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK093209 Focus ( TM) Echogenic Nerve Stimulating NeedleCook, Inc. · 2010
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K100241Contiplex D Continuous Nerve Block Set, Model 331687, 331686, 331685, 331680B.Braun Medical, Inc. · 2010 · cites it directly7descendants
- K173763iovera systemMyoscience, Inc. · 2018 · 2 generations on2descendants
- K121846Contiplex C Continuous Peripheral Nerve Block NeedleB.Braun Medical, Inc. · 2012 · 2 generations on2descendants
- K220656iovera SystemPacira Biosciences, Inc. · 2022 · 3 generations on1descendant
- K093209Focus ( TM) Echogenic Nerve Stimulating NeedleCook, Inc. · 2010 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K840287 | Brachial Plexus Anesthesia Tray | Burron Medical Products, Inc. | 1984 | — |
| −1 | K013041 | Plexolong Sets | Pajunk GmbH | 2002 | — |
| 0 (this device) | K063380 | Echostim Facet Tip | Havel'S, Inc. | 2007 | — |
| +1 | K100241 | Contiplex D Continuous Nerve Block Set, Model 331687, 331686, 331685, 331680 | B.Braun Medical, Inc. | 2010 | — |
| +2 | K173763 | iovera system | Myoscience, Inc. | 2018 | — |
| +2 | K121846 | Contiplex C Continuous Peripheral Nerve Block Needle | B.Braun Medical, Inc. | 2012 | — |
| +3 | K220656 | iovera System | Pacira Biosciences, Inc. | 2022 | — |
| +1 | K093209 | Focus ( TM) Echogenic Nerve Stimulating Needle | Cook, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 3 | 0 |
| 2012 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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.
Planning a device in BSP? 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 |
|---|---|---|---|
| * | K000722 | Unipolar NeedlesSummary page 1…Kit, Conduction Anesthetic 21CFR 868.5140 Class II Product Code: CAZ BSP E. Statement of substantial equivalence: Predicate Devices: 1. UniPlex Cannula, K000722, Pajunk Gmbh. 2. Plexalong Set, K013041, Pajunk Gmbh. The EchoStim Facet Tip Needle is substantially equivalen… | 2000 |
| * | K013041 | Plexolong SetsSummary page 1…ass II Product Code: CAZ BSP E. Statement of substantial equivalence: Predicate Devices: 1. UniPlex Cannula, K000722, Pajunk Gmbh. 2. Plexalong Set, K013041, Pajunk Gmbh. The EchoStim Facet Tip Needle is substantially equivalent to the Pajunk needle predicated devi… | 2002 |
What descends from it? (11)
See all 113 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a 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 18.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K100241 (B.Braun Medical, Inc., 2010) has gone furthest, with 7 descendants of its own.
- 8 other devices also cite its predicate K000722.
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. 2007, 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?
Havel's electrically insulated anesthesia conduction needles are used to puncture the tissue in order to gain entry and locally inject anesthetics to induce regional anesthesia. An electrical stimulus may be applied to the needle via a cable and connector to assist the physician to pinpoint the area of application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063380 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063380: Echostim Facet Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063380
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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