# K170112: IMD's Lumbar Puncture Needle

- Pathway: 510(k) (Traditional)
- Applicant: International Medical Development, Inc.(Imd)
- Decided: Feb 2, 2018 after 386 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: 4 generations back to K932249 (1993). 9 ancestors in all.
No later device cites it as a predicate yet.
2 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160294: SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles, PAJUNK GmbH Medizintechnologie (2016) Summary page 4.

## Indications for use
IMD’s Lumbar Puncture Needle, a single patient use needle; it is intended to gain entry into or puncture the: spinal cavity permitting injecting (including anesthesia) / withdrawl of fluids for purpose of diagnostic lumbar puncture myelography discography procedures. The device is intended for adult and pediatric patients. It is to be used only under the direction of a licensed clinician.

Source page: https://510kreport.com/device/K170112
Methodology: https://510kreport.com/methodology