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 Aug 25, 2010 as substantially equivalent to K093209 (Cook, Inc., 2010) after a 65-day review. Its family tree reaches back 4 generations to 1984.
- Decided
- Aug 25, 2010
- Review
- 65 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K840287 (1984). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK840287 Brachial Plexus Anesthesia TrayBurron Medical Products, Inc. · 1984
- 3 generations backK013041 Plexolong SetsPajunk GmbH · 2002
- 2 generations backK063380 Echostim Facet TipHavel'S, Inc. · 2007
- 1 generation backK093209 Focus ( TM) Echogenic Nerve Stimulating NeedleCook, Inc. · 2010
- This deviceK101728 Focus (TM) Echogenic Nerve Stimulating NeedleCook, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K840287 | Brachial Plexus Anesthesia Tray | Burron Medical Products, Inc. | 1984 | — |
| −3 | K013041 | Plexolong Sets | Pajunk GmbH | 2002 | — |
| −2 | K063380 | Echostim Facet Tip | Havel'S, Inc. | 2007 | — |
| −1 | K093209 | Focus ( TM) Echogenic Nerve Stimulating Needle | Cook, Inc. | 2010 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K093209 | Focus ( TM) Echogenic Nerve Stimulating NeedleSummary page 1…a Peripheral Nerve Stimulator andlor ultrasound guidance. Predicate Devices: 22 and 23 Gauge Cook Incorporated Focus Echogenic Nerve Stimulating Needle, 5 10(k) number K093 209. Device Description: The Focus Needle is a sterile, single use FEP-coated stainless steel needle with a B Bevel tip. The needle… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 ancestors have a recall of any class.
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/K101728 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101728: 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/K101728
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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