510(k) · Cleared

Cleared

Spinal Injection System

K083909510(k) TraditionalCleared Mar 18, 200978-day reviewClass II21 CFR 868.5150

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Laurimed, LLC · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)

Cleared on Mar 18, 2009 as substantially equivalent to K080140 (Laurimed, LLC, 2008) after a 78-day review. Its family tree reaches back 4 generations to 1980. 2 of the 19 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.

Decided: Mar 18, 2009
Review: 78 days
Class: Class II
Product code: BSP
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K801941 (1980). 17 ancestors in all. 1 later device descends from it, 1 citing it directly. 2 of the 19 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 4 generations backK801941 Burron Microcath Intra. Cath. PlacementtBurron Medical Products, Inc. · 1980
3 generations backK982805 Introcan Safety IV CatheterB.Braun Medical, Inc. · 1999 · Recalled
2 generations backK020785 Introcan Safety IV CatheterB.Braun Medical, Inc. · 2002 · Recalled
1 generation backK080140 Laurimed Spinal Injection SystemLaurimed, LLC · 2008
This deviceK083909 Spinal Injection SystemLaurimed, LLC · 2009
Descendant · cites it directly · 0 of its ownK091818 Laurimed Spinal Injection SystemLaurimed, LLC · 2009

Class I recalls in this family

K911202 Atraumatic Standard Sprotte Needle3 generations back · 1992
K911260 Atraumatic Standard Sprotte Needle3 generations back · 1991

Most influential descendants

Showing 1 of 1 · See all

K091818Laurimed Spinal Injection SystemLaurimed, LLC · 2009 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K801941	Burron Microcath Intra. Cath. Placementt	Burron Medical Products, Inc.	1980	—
−3	K982805	Introcan Safety IV Catheter	B.Braun Medical, Inc.	1999	1
−2	K020785	Introcan Safety IV Catheter	B.Braun Medical, Inc.	2002	2
−1	K080140	Laurimed Spinal Injection System	Laurimed, LLC	2008	—
0 (this device)	K083909	Spinal Injection System	Laurimed, LLC	2009	—
+1	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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

FIG. 1 — Lineage of K083909, 1980–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K080140	Laurimed Spinal Injection System Summary page 1 …Product Code BSP) E. Predicate Devices The Laurimed Spinal Injection System is substantially equivalent to the Laurimed Spinal Injection System (K080140). F. Device Description The Laurimed Spinal Injection System integrates a flexible Catheter with an atraumatic di…	Laurimed, LLC	2008	—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K091818	Laurimed Spinal Injection System	Laurimed, LLC	2009	0

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.

K911202Atraumatic Standard Sprotte NeedlePajunk GmbH · 1992 · 3 generations back · ◆ in the 1992 ancestors bar of FIG. 11 Class I recall
K911260Atraumatic Standard Sprotte NeedlePajunk GmbH · 1991 · 3 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
7 of the 17 ancestors have a recall of any class; 2 have a Class I recall.
Of its descendants, K091818 (Laurimed, LLC, 2009) has gone furthest, with 0 descendants of its own.

How does its category compare?

All BSP devices

BSP 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

2007high 8 (2008) · low 0 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BSP

170in 2025

2007high 269 (2020) · low 70 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BSP

1in 2020

2007high 1 (2016) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · BSP

86in 2025

2007high 152 (2016) · low 20 (2012)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?

Spinal epidural injections for the administration of contrast media, anesthetic agents to provide regional anesthesia, and anti-inflammatory medications. Not for use with other needles or catheters.

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/K083909 · printed Nov 4, 2026

Cite this page

510(k) Report. “K083909: 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/K083909

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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