# K041843: Pencil Point Needle

- Pathway: 510(k) (Traditional)
- Applicant: Epimed International, Inc.
- Decided: Aug 24, 2004 after 47 days
- Product code: BSP (Needle, Conduction, Anesthetic (W/Wo Introducer))
- Device class: 2
- Regulation: 21 CFR 868.5150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K911260 (1991). 3 ancestors in all.
9 later devices descend from it; 3 cite it directly.
2 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911260: Atraumatic Standard Sprotte Needle, Pajunk GmbH (1991) Summary page 1.
- K911221: Atraumatic Special Sprotte Needle, Pajunk GmbH (1992) Summary page 1.
- K911202: Atraumatic Standard Sprotte Needle, Pajunk GmbH (1992) Summary page 1.

## Most influential descendants
- K142553: UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle (2015), 3 descendants of its own
- K171518: Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles (2018), 2 descendants of its own
- K080140: Laurimed Spinal Injection System (2008), 2 descendants of its own
- K083909: Spinal Injection System (2009), 1 descendant of its own
- K052946: MPS Acacia Nerve Block Needle (2005), 1 descendant of its own

## Recalls of this device
- Jul 24, 2017 · Class II · Z-0088-2018: Potential for partially incomplete seal of product, impacting sterility.

## Indications for use
The Blunt Nerve Block Needle is intended for the administration of anesthetic agents to provide regional anesthesia.

Source page: https://510kreport.com/device/K041843
Methodology: https://510kreport.com/methodology