510(k) · Cleared
ClearedFocus ( TM) Echogenic Nerve Stimulating Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Feb 26, 2010 as substantially equivalent to K063380 (Havel'S, Inc., 2007) and 1 other predicate after a 136-day review. Its family tree reaches back 3 generations to 1984. 1 later device descends from it.
- Decided
- Feb 26, 2010
- Review
- 136 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K840287 (1984). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK840287 Brachial Plexus Anesthesia TrayBurron Medical Products, Inc. · 1984
- 2 generations backK013041 Plexolong SetsPajunk GmbH · 2002
- 1 generation backK063380 Echostim Facet TipHavel'S, Inc. · 2007
- This deviceK093209 Focus ( TM) Echogenic Nerve Stimulating NeedleCook, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK101728 Focus (TM) Echogenic Nerve Stimulating NeedleCook, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K101728Focus (TM) Echogenic Nerve Stimulating NeedleCook, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K840287 | Brachial Plexus Anesthesia Tray | Burron Medical Products, Inc. | 1984 | — |
| −2 | K013041 | Plexolong Sets | Pajunk GmbH | 2002 | — |
| −1 | K063380 | Echostim Facet Tip | Havel'S, Inc. | 2007 | — |
| 0 (this device) | K093209 | Focus ( TM) Echogenic Nerve Stimulating Needle | Cook, Inc. | 2010 | — |
| +1 | K101728 | Focus (TM) Echogenic Nerve Stimulating Needle | Cook, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 |
|---|---|---|---|
| * | K063380 | Echostim Facet TipSummary page 2…ntially equivalent to the EchoStim. Facet Tip Needle manufactured by Hakko Medical Co., Ltd. of Japan and distributed in the U.S. by Havel's Inc. under 5 10(k) clearance K0633 80. The Focus Echogenic Nerve Stimulating Needle is also substantially equivalent to the Temena Hybrid Nerve Location Needle manufac… | 2007 |
| * | K080603 | Hybrid Nerve Location Needle Coated and UncoatedSummary page 2…The Focus Echogenic Nerve Stimulating Needle is also substantially equivalent to the Temena Hybrid Nerve Location Needle manufactured by TE ME NA under 5 10(k) clearance K080603. 4. Device Description: The Focus Needle is a sterile, single use FEP-coated stainless steel needle with a B Bevel tip. The nee… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101728 | Focus (TM) Echogenic Nerve Stimulating Needle | 2010 | 0 |
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 26 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K101728 (Cook, Inc., 2010) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K063380.
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. 2010, 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 FocusTm Echogenic Nerve Stimulating Needle is intended for locating and stimulating peripheral nerves and nerve plexuses for nerve block anesthesia techniques using a Peripheral Nerve Stimulator and/or ultrasound guidance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093209 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093209: Focus ( TM) Echogenic Nerve Stimulating Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093209
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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