510(k) · Cleared
ClearedBallard Medical Products Epidural and Spinal Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ballard Medical Products · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Mar 28, 2000 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Mar 28, 2000
- Review
- 42 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK000495 Ballard Medical Products Epidural and Spinal NeedlesBallard Medical Products · 2000
- Descendant · cites it directly · 1 of its ownK090261 Portex Tuohy Epidural Needle 17G, Portex Tuohy Epidural Needle 18GSmiths Medical Asd, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK172823 Portex NRFit Epidural NeedlesSmiths Medical Asd, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK013892 Lutz NeedleBallard Medical Products · 2002
Most influential descendants
Showing 3 of 3 · See all- K090261Portex Tuohy Epidural Needle 17G, Portex Tuohy Epidural Needle 18GSmiths Medical Asd, Inc. · 2009 · cites it directly1descendant
- K172823Portex NRFit Epidural NeedlesSmiths Medical Asd, Inc. · 2018 · 2 generations on0descendants
- K013892Lutz NeedleBallard Medical Products · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000495 | Ballard Medical Products Epidural and Spinal Needles | Ballard Medical Products | 2000 | — |
| +1 | K090261 | Portex Tuohy Epidural Needle 17G, Portex Tuohy Epidural Needle 18G | Smiths Medical Asd, Inc. | 2009 | — |
| +2 | K172823 | Portex NRFit Epidural Needles | Smiths Medical Asd, Inc. | 2018 | — |
| +1 | K013892 | Lutz Needle | Ballard Medical Products | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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, K090261 (Smiths Medical Asd, Inc., 2009) 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.
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) | — |
https://510kreport.com/device/K000495 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000495: Ballard Medical Products Epidural and Spinal Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000495
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026