510(k) · Cleared
ClearedLaurimed Spinal Injection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laurimed, LLC · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Sep 23, 2009 as substantially equivalent to K083909 (Laurimed, LLC, 2009) after a 97-day review. Its family tree reaches back 5 generations to 1980. 2 of the 19 devices in its family, counting itself, have a Class I recall.
- Decided
- Sep 23, 2009
- Review
- 97 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K801941 (1980). 18 ancestors in all. No later device cites it as a predicate yet. 2 of the 19 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK801941 Burron Microcath Intra. Cath. PlacementtBurron Medical Products, Inc. · 1980
- 4 generations backK982805 Introcan Safety IV CatheterB.Braun Medical, Inc. · 1999 · Recalled
- 3 generations backK020785 Introcan Safety IV CatheterB.Braun Medical, Inc. · 2002 · Recalled
- 2 generations backK080140 Laurimed Spinal Injection SystemLaurimed, LLC · 2008
- 1 generation backK083909 Spinal Injection SystemLaurimed, LLC · 2009
- This deviceK091818 Laurimed Spinal Injection SystemLaurimed, LLC · 2009
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K801941 | Burron Microcath Intra. Cath. Placementt | Burron Medical Products, Inc. | 1980 | — |
| −4 | K982805 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 1999 | 1 |
| −3 | K020785 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 2002 | 2 |
| −2 | K080140 | Laurimed Spinal Injection System | Laurimed, LLC | 2008 | — |
| −1 | K083909 | Spinal Injection System | Laurimed, LLC | 2009 | — |
| 0 (this device) | K091818 | Laurimed Spinal Injection System | Laurimed, LLC | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 1 |
| 1992 | 2 | 1 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 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.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BSP device
- #1 K241954 SonoBlock; SonoBlock IIscore 11.0 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K083909 | Spinal Injection SystemSummary page 1…Product Code BSP) E. Predicate Devices The Trucath Spinal Injection System is substantially equivalent to the Laurimed Spinal Injection System (K083909). F. Device Description The Trucath Spinal Injection System integrates a flexible Catheter with an atraumatic dis… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 7 of the 18 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All BSP devicesBSP Needle, Conduction, Anesthetic (W/Wo Introducer): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · BSP
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSP
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSP
1in 2020
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BSP
86in 2025
MAUDE reports naming product code BSP, 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 | 3 | 189 | 0 | 26 |
| 2008 | 8 | 127 | 0 | 24 |
| 2009 | 5 | 97 | 0 | 30 |
| 2010 | 3 | 79 | 0 | 49 |
| 2011 | 3 | 114 | 0 | 33 |
| 2012 | 3 | 148 | 0 | 20 |
| 2013 | 2 | — | 0 | 32 |
| 2014 | 2 | — | 0 | 41 |
| 2015 | 2 | — | 0 | 38 |
| 2016 | 6 | 268 | 1 | 152 |
| 2017 | 4 | 186 | 0 | 34 |
| 2018 | 8 | 241 | 0 | 69 |
| 2019 | 2 | — | 1 | 86 |
| 2020 | 3 | 269 | 1 | 78 |
| 2021 | 3 | 265 | 0 | 52 |
| 2022 | 2 | — | 0 | 84 |
| 2023 | 0 | — | 0 | 75 |
| 2024 | 3 | 70 | 0 | 66 |
| 2025 | 4 | 170 | 0 | 86 |
| 2026 | 0 | — | 1 (1) | — |
What is it indicated for?
The TruCath Spinal Injection System is indicated for use in injections into the epidural space. Not for use with other catheters or needles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091818 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091818: Laurimed Spinal Injection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091818
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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