510(k) · Cleared
ClearedSims Adult Lumbar Puncture Kit (4800-20,4801-20,4806-22,4807-22)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Industries Medical Systems, Inc. · FMJ Manometer, Spinal-Fluid
Cleared on Oct 18, 1996 after a 43-day review. The FDA summary names its predicate without a number.
- Decided
- Oct 18, 1996
- Review
- 43 days
- Class
- Class II
- Product code
- FMJ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FMJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | American Pharmaseal® Company’s Pediatric/Infant Lumbar Puncture Tray Named without a submission number | |
| * | — | Abbott Laboratories’ Lumbar Puncture, Child, 22-G x 3 1/2”, Double-Decker Tray with… Named without a submission number | |
| * | — | Abbott Laboratories’ Lumbar Puncture, Adult, 20-G x 3 1/2”, Double-Decker Tray with… Named without a submission number | |
| † | K851134 | Regional Anesthesia Trays | 1985 |
| † | K833171 | Monitoring Kit | 1984 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All FMJ devicesFMJ Manometer, Spinal-Fluid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMJ
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · FMJ
Too few FMJ 510(k)s in any year since 2007 to give a median.
Recalls per year · FMJ
No recall names FMJ since 2007.
Adverse event reports per year · FMJ
1in 2025
MAUDE reports naming product code FMJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 28 |
| 2013 | 0 | — | 0 | 101 |
| 2014 | 0 | — | 0 | 176 |
| 2015 | 0 | — | 0 | 84 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963570 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963570: Sims Adult Lumbar Puncture Kit (4800-20,4801-20,4806-22,4807-22).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963570
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026