510(k) · Cleared
ClearedBD Spinal Needle 27G
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton Dickson & Co. · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Oct 9, 2009 after a 115-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Oct 9, 2009
- Review
- 115 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK091758 BD Spinal Needle 27GBecton Dickson & Co. · 2009
- Descendant · cites it directly · 1 of its ownK163435 Entellus Medical Reinforced Anesthesia NeedleEntellus Medical, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK240253 Reach NeedleAerin Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK210978 BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal…Becton, Dickinson and Company · 2021
Most influential descendants
Showing 3 of 3 · See all- K163435Entellus Medical Reinforced Anesthesia NeedleEntellus Medical, Inc. · 2017 · cites it directly1descendant
- K240253Reach NeedleAerin Medical, Inc. · 2024 · 2 generations on0descendants
- K210978BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer NeedleBecton, Dickinson and Company · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091758 | BD Spinal Needle 27G | Becton Dickson & Co. | 2009 | — |
| +1 | K163435 | Entellus Medical Reinforced Anesthesia Needle | Entellus Medical, Inc. | 2017 | — |
| +2 | K240253 | Reach Needle | Aerin Medical, Inc. | 2024 | — |
| +1 | K210978 | BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle | Becton, Dickinson and Company | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | — | BD Spinal Needle 25G Named without a submission number | |
| * | — | BD Spinal Needle 27G Named without a submission number |
What descends from it? (3)
2 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?
- Of its descendants, K163435 (Entellus Medical, Inc., 2017) 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. 2009, 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?
An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091758 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091758: BD Spinal Needle 27G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091758
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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