510(k) · Cleared
ClearedBallpen Spinal Needle W/WO Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rusch Intl. · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Nov 16, 2001 after a 218-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Nov 16, 2001
- Review
- 218 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK011122 Ballpen Spinal Needle W/WO IntroducerRusch Intl. · 2001
- Descendant · cites it directly · 6 of its ownK112515 Pencan Spinal NeedleB.Braun Medical, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK141126 Uniever Disposable Spinal Anesthesia NeedleUnisis Corp. · 2014
- Descendant · 3 generations on · 2 of its ownK171518 Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined…Zhejiang Kindly Medical Devices Co., Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK170900 DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe +…Intervene Group, Ltd. · 2017
- Descendant · 4 generations on · 0 of its ownK212982 Medispine - Spinal Needle, Glospine - Spinal NeedleGlobal Medikit Limited · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K112515Pencan Spinal NeedleB.Braun Medical, Inc. · 2011 · cites it directly6descendants
- K141126Uniever Disposable Spinal Anesthesia NeedleUnisis Corp. · 2014 · 2 generations on3descendants
- K171518Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia NeedlesZhejiang Kindly Medical Devices Co., Ltd. · 2018 · 3 generations on2descendants
- K170900DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6…Intervene Group, Ltd. · 2017 · 2 generations on1descendant
- K212982Medispine - Spinal Needle, Glospine - Spinal NeedleGlobal Medikit Limited · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011122 | Ballpen Spinal Needle W/WO Introducer | Rusch Intl. | 2001 | — |
| +1 | K112515 | Pencan Spinal Needle | B.Braun Medical, Inc. | 2011 | — |
| +2 | K141126 | Uniever Disposable Spinal Anesthesia Needle | Unisis Corp. | 2014 | — |
| +3 | K171518 | Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia… | Zhejiang Kindly Medical Devices Co., Ltd. | 2018 | — |
| +2 | K170900 | DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe +… | Intervene Group, Ltd. | 2017 | — |
| +4 | K212982 | Medispine - Spinal Needle, Glospine - Spinal Needle | Global Medikit Limited | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 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? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112515 | Pencan Spinal Needle | 2011 | 6 |
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, K112515 (B.Braun Medical, Inc., 2011) has gone furthest, with 6 descendants 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/K011122 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011122: Ballpen Spinal Needle W/WO Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011122
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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