510(k) · Cleared
Recalled · Class II · 2017Pencil Point Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epimed International, Inc. · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Aug 24, 2004 as substantially equivalent to K911260 (Pajunk GmbH, 1991) and 2 other predicates after a 47-day review. Its family tree reaches back 1 generation to 1991. 2 of the 13 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it. It has been recalled once.
- Decided
- Aug 24, 2004
- Review
- 47 days
- Class
- Class II
- Product code
- BSP
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K911260 (1991). 3 ancestors in all. 9 later devices descend from it, 3 citing it directly. 2 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK911260 Atraumatic Standard Sprotte NeedlePajunk GmbH · 1991 · Recalled (Class I)
- This deviceK041843 Pencil Point NeedleEpimed International, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK142553 UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable…Unisis Corp. · 2015
- 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 · 2 of its ownK080140 Laurimed Spinal Injection SystemLaurimed, LLC · 2008
- Descendant · 2 generations on · 1 of its ownK083909 Spinal Injection SystemLaurimed, LLC · 2009
- Descendant · cites it directly · 1 of its ownK052946 MPS Acacia Nerve Block NeedleMps Acacia · 2005
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · See all- K142553UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked NeedleUnisis Corp. · 2015 · cites it directly3descendants
- K171518Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia NeedlesZhejiang Kindly Medical Devices Co., Ltd. · 2018 · 2 generations on2descendants
- K080140Laurimed Spinal Injection SystemLaurimed, LLC · 2008 · cites it directly2descendants
- K083909Spinal Injection SystemLaurimed, LLC · 2009 · 2 generations on1descendant
- K052946MPS Acacia Nerve Block NeedleMps Acacia · 2005 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911260 | Atraumatic Standard Sprotte Needle | Pajunk GmbH | 1991 | Class I |
| 0 (this device) | K041843 | Pencil Point Needle | Epimed International, Inc. | 2004 | — |
| +1 | K142553 | UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve… | Unisis Corp. | 2015 | — |
| +2 | K171518 | Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia… | Zhejiang Kindly Medical Devices Co., Ltd. | 2018 | — |
| +1 | K080140 | Laurimed Spinal Injection System | Laurimed, LLC | 2008 | — |
| +2 | K083909 | Spinal Injection System | Laurimed, LLC | 2009 | — |
| +1 | K052946 | MPS Acacia Nerve Block Needle | Mps Acacia | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K911260 | Atraumatic Standard Sprotte NeedleSummary page 1…: Blunt Nerve Block Needle Common Name: Pencil Point Needle Product Class/Classification: Class B Predicate Device(s): Pajunk Sprotte Needles (K911260, K911221, K911202) Description: The Blunt Nerve Block Needle consists of a stainless steel cannula with an atmumatic… | 1991 |
| * | K911221 | Atraumatic Special Sprotte NeedleSummary page 1…lunt Nerve Block Needle Common Name: Pencil Point Needle Product Class/Classification: Class B Predicate Device(s): Pajunk Sprotte Needles (K911260, K911221, K911202) Description: The Blunt Nerve Block Needle consists of a stainless steel cannula with an atmumatic distal ti… | 1992 |
| * | K911202 | Atraumatic Standard Sprotte NeedleSummary page 1…e Block Needle Common Name: Pencil Point Needle Product Class/Classification: Class B Predicate Device(s): Pajunk Sprotte Needles (K911260, K911221, K911202) Description: The Blunt Nerve Block Needle consists of a stainless steel cannula with an atmumatic distal tip. A plas… | 1992 |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 24, 2017 | Class II | Z-0088-2018 | Employee error | Potential for partially incomplete seal of product, impacting sterility. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
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.
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 Blunt Nerve Block Needle is intended for the administration of anesthetic agents to provide regional anesthesia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041843 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041843: Pencil Point Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041843
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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