510(k) · Cleared
Recalled · Class II · 2014Hybrid Nerve Location Needle Coated and Uncoated
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Te ME NA Sas · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Aug 5, 2008 as substantially equivalent to K990100 (Te ME NA S.A.R.L., 2000) after a 155-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 5, 2008
- Review
- 155 days
- Class
- Class II
- Product code
- BSP
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K990100 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK990100 Polymedic Upa Nerve Stimulation Needle; Polymedic Upc Nerve…Te ME NA S.A.R.L. · 2000 · Recalled
- This deviceK080603 Hybrid Nerve Location Needle Coated and UncoatedTe ME NA Sas · 2008
- Descendant · cites it directly · 1 of its ownK093209 Focus ( TM) Echogenic Nerve Stimulating NeedleCook, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK101728 Focus (TM) Echogenic Nerve Stimulating NeedleCook, Inc. · 2010
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 |
|---|---|---|---|---|---|
| −1 | K990100 | Polymedic Upa Nerve Stimulation Needle; Polymedic Upc Nerve Stimulation Needle | Te ME NA S.A.R.L. | 2000 | 19 |
| 0 (this device) | K080603 | Hybrid Nerve Location Needle Coated and Uncoated | Te ME NA Sas | 2008 | — |
| +1 | K093209 | Focus ( TM) Echogenic Nerve Stimulating Needle | Cook, Inc. | 2010 | — |
| +2 | K101728 | Focus (TM) Echogenic Nerve Stimulating Needle | Cook, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 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 |
|---|---|---|---|
| * | K990100 | Polymedic Upa Nerve Stimulation Needle; Polymedic Upc Nerve Stimulation NeedleSummary page 1…rsion) may be used for echo nerve location and the Hybrid (coated version) for both stimulator and echo location. Predicate Device: Temena UPC Nerve Stimulator Needle - K990100 Havel Echostim Facit Tip K063380 Substantial Equivalence: The Temena Hybrid needle is identical to the already cl… | 2000 |
| † | K063380 | Echostim Facet Tip | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093209 | Focus ( TM) Echogenic Nerve Stimulating Needle | 2010 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 19, 2014 | Class II | Z-1609-2014 | Process design | Ultrasound needles may be defective and leak at the needle hub. |
| Mar 19, 2014 | Class II | Z-1608-2014 | Process design | Ultrasound needles may be defective and leak at the needle hub. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K093209 (Cook, Inc., 2010) has gone furthest, with 1 descendant of its own.
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. 2008, 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 Temena Nerve Location Needles are intended for use in regional anesthesia procedures, by anesthesiologists or other trained professionals, for the location of peripheral nerves with a nerve stimulator and/or with an ultrasound device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080603 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080603: Hybrid Nerve Location Needle Coated and Uncoated.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080603
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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