# K980536: Epidural Needle

- Pathway: 510(k) (Traditional)
- Applicant: Manan Medical Products, Inc.
- Decided: Jul 31, 1998 after 170 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K030562: Tuohy Epidural Needle (2003), 2 descendants of its own
- K053318: RX Epidural Needle (2006), 1 descendant of its own
- K072005: RK Epidural Needle (2008), 0 descendants of its own
- K032981: Sppro Esp, Models Esp 603-18-05, Esp 603-18-09 (2004), 0 descendants of its own

## Indications for use
For the epidural placement, directly or through a catheter, of anesthetic agents to elicit regional anesthesia.

Source page: https://510kreport.com/device/K980536
Methodology: https://510kreport.com/methodology