510(k) · Cleared
ClearedSPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectra Medical Devices, Inc. · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Feb 5, 2016 as substantially equivalent to K063380 (Havel'S, Inc., 2007) after a 290-day review. Its family tree reaches back 3 generations to 1984.
- Decided
- Feb 5, 2016
- Review
- 290 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K840287 (1984). 4 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK151069 SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia…Spectra Medical Devices, Inc. · 2016
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) | K151069 | SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle | Spectra Medical Devices, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 |
|---|---|---|---|
| * | K063380 | Echostim Facet TipSummary page 4…le, Anesthesia Conduction Device Panel: Anesthesiology Regulatory Class: 2 Product Code: BSP Contact Type: Limited Exposure Device PREDICATE DEVICE e Havel’s Inc. — K063380 ECHOSTIM FACIT TIP These predicates have not been subject to a design-related recall. No reference devices were used in this sub… | 2007 |
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 32 years and passes through 4 companies; a new generation was cleared every 8.8 years on median.
- None of the 4 ancestors has a recall.
- 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. 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 SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle is intended for use in injecting a single dose of local anesthetic or analgesic into a patient for regional anesthesia or pain therapy with the echogenic reflective pattern providing visualization of the needle tip using Ultrasound Imaging. The needles are intended to mate with the male connector of a Luer Lock or Luer Slip Syringe or extension set.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151069 · printed Nov 3, 2026
Cite this page
510(k) Report. “K151069: SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K151069
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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