# K211085: BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Jul 1, 2022 after 445 days
- Product code: BSP (Needle, Conduction, Anesthetic (W/Wo Introducer))
- Device class: 2
- Regulation: 21 CFR 868.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K932249 (1993). 25 ancestors in all.
No later device cites it as a predicate yet.
2 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171518: Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles, Zhejiang Kindly Medical Devices Co., Ltd. (2018) Summary page 4.

## Indications for use
BD Perisafe™ Tuohy Epidural Needle and BD Perisafe™ Weiss Epidural Needle are indicated for the administration of anesthesia or analgesia into the epidural space, or to introduce a dedicated catheter for continuous administration of anesthesia or analgesia into the epidural space. They can also be used to introduce a spinal needle to perform a combined spinal and epidural procedure. These devices are intended for adult and pediatric patients.

Source page: https://510kreport.com/device/K211085
Methodology: https://510kreport.com/methodology