510(k) · Cleared
ClearedPencan Spinal Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Dec 22, 2011 as substantially equivalent to K932569 (B. Braun of America, Inc., 1994) and 2 other predicates after a 114-day review. Its family tree reaches back 1 generation to 1982. 6 later devices descend from it.
- Decided
- Dec 22, 2011
- Review
- 114 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K820047 (1982). 3 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK820047 Spinocan Spinal NeedleBurron Medical Products, Inc. · 1982 · Recalled
- This deviceK112515 Pencan Spinal NeedleB.Braun Medical, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK141126 Uniever Disposable Spinal Anesthesia NeedleUnisis Corp. · 2014
- Descendant · 2 generations on · 2 of its ownK171518 Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined…Zhejiang Kindly Medical Devices Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK170900 DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe +…Intervene Group, Ltd. · 2017
- Descendant · 3 generations on · 0 of its ownK212982 Medispine - Spinal Needle, Glospine - Spinal NeedleGlobal Medikit Limited · 2022
- Descendant · 3 generations on · 0 of its ownK211085 BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural NeedleBecton, Dickinson and Company · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K141126Uniever Disposable Spinal Anesthesia NeedleUnisis Corp. · 2014 · cites it directly3descendants
- K171518Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia NeedlesZhejiang Kindly Medical Devices Co., Ltd. · 2018 · 2 generations on2descendants
- K170900DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6…Intervene Group, Ltd. · 2017 · cites it directly1descendant
- K212982Medispine - Spinal Needle, Glospine - Spinal NeedleGlobal Medikit Limited · 2022 · 3 generations on0descendants
- K211085BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural NeedleBecton, Dickinson and Company · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K820047 | Spinocan Spinal Needle | Burron Medical Products, Inc. | 1982 | 1 |
| 0 (this device) | K112515 | Pencan Spinal Needle | B.Braun Medical, Inc. | 2011 | — |
| +1 | K141126 | Uniever Disposable Spinal Anesthesia Needle | Unisis Corp. | 2014 | — |
| +2 | K171518 | Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia… | Zhejiang Kindly Medical Devices Co., Ltd. | 2018 | — |
| +1 | K170900 | DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe +… | Intervene Group, Ltd. | 2017 | — |
| +3 | K212982 | Medispine - Spinal Needle, Glospine - Spinal Needle | Global Medikit Limited | 2022 | — |
| +3 | K211085 | BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle | Becton, Dickinson and Company | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (3)
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 |
|---|---|---|---|
| * | K932569 | Pencil Point Spinal Needle and TraySummary page 1…DEVICE CLASSIFICATION: Class II, Product Code BSP, 21 CER 868.5150 PREDICATE DEVICES: Pencil Point Spinal Needle, B. Braun Medical Inc., K932569, Class 11, BSP, 868.5150. Spinocan Spinal Needle, B. Braun Medica… | 1994 |
| * | K820047 | Spinocan Spinal NeedleSummary page 1…, B. Braun Medical Inc., K932569, Class 11, BSP, 868.5150. Spinocan Spinal Needle, B. Braun Medical Inc., K820047, Class 11, BSP, 868.5150 Balipen Spinal Needle, RUSCH INTL, K01 1… | 1982 |
| * | K011122 | Ballpen Spinal Needle W/WO IntroducerSummary page 1…Spinal Needle, B. Braun Medical Inc., K820047, Class 11, BSP, 868.5150 Balipen Spinal Needle, RUSCH INTL, K01 1122, Class 11, BSP, 868.5150 DESCRIPTION: The B. Braun Pencan Spinal Needle consi… | 2001 |
What descends from it? (6)
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?
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. 2011, 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 Pencan spinal needles with or without introducer are intended for the injection of local anesthetics into the subarachnoid space to provide spinal anesthesia for pain management or to facilitate CSF sample collection for diagnostic purposes (lumbar puncture). The needles are intended for use in any target population with consideration given to the anatomy of the patient. The Spinocan spinal needles with or without introducer are intended for the…
Read the full statement (114 words)
The Pencan spinal needles with or without introducer are intended for the injection of local anesthetics into the subarachnoid space to provide spinal anesthesia for pain management or to facilitate CSF sample collection for diagnostic purposes (lumbar puncture). The needles are intended for use in any target population with consideration given to the anatomy of the patient.
The Spinocan spinal needles with or without introducer are intended for the injection of local anesthetics into the subarachnoid space to provide spinal anesthesia for pain management or to facilitate CSF sample collection for diagnostic purposes (lumbar puncture). The needles are intended for use in any target population with consideration given to the anatomy of the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112515: Pencan Spinal Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112515
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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