510(k) · Cleared
ClearedLumbar Puncture Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · FMJ Manometer, Spinal-Fluid
Cleared on Apr 7, 1997 as substantially equivalent to K932569 (B. Braun of America, Inc., 1994) and 1 other predicate after a 73-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Apr 7, 1997
- Review
- 73 days
- Class
- Class II
- Product code
- FMJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K920305 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK920305 Pharmaseal Clear Hub Spinal NeedleBaxter Healthcare Corp · 1993
- This deviceK970287 Lumbar Puncture KitB.Braun Medical, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920305 | Pharmaseal Clear Hub Spinal Needle | Baxter Healthcare Corp | 1993 | — |
| 0 (this device) | K970287 | Lumbar Puncture Kit | B.Braun Medical, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K932569 | Pencil Point Spinal Needle and TraySummary page 1…ture Kit CLASSIFICATION NAME: General Hospital Class II, 80 FMJ, Spinal Fluid Manometer 21 CFR 880.2500 SUBSTANTIAL EQUIVALENCE' TO: 510 (k) number Name Applicant B K932569 Pencil Point Spinal |B. Braun of America Needle and Tray K920305 Pharmaseal Clear Hub | Baxter Healthcare Spinal Needle Corporat… | 1994 |
| * | K920305 | Pharmaseal Clear Hub Spinal NeedleSummary page 1…Spinal Fluid Manometer 21 CFR 880.2500 SUBSTANTIAL EQUIVALENCE' TO: 510 (k) number Name Applicant B K932569 Pencil Point Spinal |B. Braun of America Needle and Tray K920305 Pharmaseal Clear Hub | Baxter Healthcare Spinal Needle Corporation DEVICE DESCRIPTION: In accordance with section 510(k) for th… | 1993 |
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.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K932569.
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 Lumbar Puncture Kit is designed to collect samples of cerebralspinal fluid (CSF) from a patient while undergoing a lumbar puncture procedure. This device is also designed to attach a manometer to measure intracranial pressure (ICP), detect blood in CSF, inject dyes and gasses into the spine for radiologic studies, and to administer drugs or anesthesia between the third and fourth lumbar vertebrae in adult or pediatric patients.
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/K970287 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970287: Lumbar Puncture Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970287
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026