# K911260: Atraumatic Standard Sprotte Needle

- Pathway: 510(k) (Traditional)
- Applicant: Pajunk GmbH
- Decided: Oct 21, 1991 after 213 days
- Product code: BSP (Needle, Conduction, Anesthetic (W/Wo Introducer))
- Device class: 2
- Regulation: 21 CFR 868.5150
- Recalls of this device: 5 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
40 later devices descend from it; 5 cite it directly.
1 of 41 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K040965: Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles (2004), 36 descendants of its own
- K113207: Sono Tap, Tuohy Sono (2012), 11 descendants of its own
- K041843: Pencil Point Needle (2004), 9 descendants of its own
- K070354: Imd's Anesthesia Needles (Tuohy, Quincke and Pencil Point) (2007), 7 descendants of its own
- K131006: Anesthesia Conduction Needles (2013), 5 descendants of its own

## Recalls of this device
- Apr 21, 2026 · Class I · Z-2389-2026: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffect
- Dec 20, 2019 · Class II · Z-1250-2020: Product lidstock contains the incorrect expiration date for the product
- Oct 11, 2019 · Class II · Z-2129-2020: Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified a packaging
- Oct 11, 2019 · Class II · Z-2130-2020: Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified a packaging
- Aug 30, 2019 · Class II · Z-0234-2020: Problem with packaging sealing process which affects sterility.

Source page: https://510kreport.com/device/K911260
Methodology: https://510kreport.com/methodology