# K963570: Sims Adult Lumbar Puncture Kit (4800-20,4801-20,4806-22,4807-22)

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Industries Medical Systems, Inc.
- Decided: Oct 18, 1996 after 43 days
- Product code: FMJ (Manometer, Spinal-Fluid)
- Device class: 2
- Regulation: 21 CFR 880.2500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) American Pharmaseal® Company’s Pediatric/Infant Lumbar Puncture Tray: named in the summary without a submission number
- (no number) Abbott Laboratories’ Lumbar Puncture, Child, 22-G x 3 1/2”, Double-Decker Tray with Lidocaine Hydrochloride: named in the summary without a submission number
- (no number) Abbott Laboratories’ Lumbar Puncture, Adult, 20-G x 3 1/2”, Double-Decker Tray with Lidocaine Hydrochloride: named in the summary without a submission number

## Indications for use
The SIMS Lumbar Puncture (LP) Kit is indicated for sampling of Cerebrospmal Fluid (CSF) and the measurement of CSF pressure as indicated in standard textbooks'* The SIMS LP Kits are intended to be used when Lumbar Puncture is performed to obtain a CSF sfiééimen for diagnostic study when possible CNS infection is suspected, such as sepsis and/or meningitis. The procedure can also be used to measure increased intracranial pressure which can result from infection, tumor, hemorrhage or edema. This technique is also used to lower intracranial pressure by CSF drainage. CSF pressure is measured prior to CSF sampling using a manometer.

Source page: https://510kreport.com/device/K963570
Methodology: https://510kreport.com/methodology