# K142553: UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle

- Pathway: 510(k) (Traditional)
- Applicant: Unisis Corp.
- Decided: Jan 14, 2015 after 126 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: 5 generations back to K932249 (1993). 16 ancestors in all.
3 later devices descend from it; 1 cites it directly.
2 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131006: Anesthesia Conduction Needles, Lccs Products Limited (2013) Summary page 4.
- K040965: Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles, Pajunk GmbH (2004) Summary page 4.
- K113207: Sono Tap, Tuohy Sono, Pajunk GmbH (2012) Summary page 4.
- K041843: Pencil Point Needle, Epimed International, Inc. (2004) Summary page 4.
- K081864: Prolong, Life-Tech, Inc. (2008) Summary page 4.

## Most influential descendants
- K171518: Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles (2018), 2 descendants of its own
- K212982: Medispine - Spinal Needle, Glospine - Spinal Needle (2022), 0 descendants of its own
- K211085: BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle (2022), 0 descendants of its own

## Indications for use
The Uniever Disposable Epidural Anesthesia Needle is intended to be used for injection into the epidural space / or placing the epidural catheter into the epidural space. Uniever Disposable Nerve Blockade Needle is intended to be used for injection of local anesthetic agent near the nerve for temporary pain control.

Source page: https://510kreport.com/device/K142553
Methodology: https://510kreport.com/methodology