510(k) · Cleared

Cleared

Laurimed Percutaneous Discectomy System, Model FG-000002

K082194510(k) TraditionalCleared Aug 28, 200824-day reviewClass II21 CFR 888.1100

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

Cleared on Aug 28, 2008 as substantially equivalent to K923525 (Surgical Dynamics, Inc., 1993) and 1 other predicate after a 24-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.

Decided: Aug 28, 2008
Review: 24 days
Class: Class II
Product code: HRX
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K914282 (1991). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK914282 Nucleotome (R) II (VERSION2) Tissue Aspira/CutterSurgical Dynamics, Inc. · 1991
This deviceK082194 Laurimed Percutaneous Discectomy System, Model FG-000002Laurimed, LLC · 2008
Descendant · cites it directly · 0 of its ownK090815 Percutaneous Discectomy SystemLaurimed, LLC · 2009

Most influential descendants

Showing 1 of 1 · See all

K090815Percutaneous Discectomy SystemLaurimed, LLC · 2009 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K914282	Nucleotome (R) II (VERSION2) Tissue Aspira/Cutter	Surgical Dynamics, Inc.	1991	—
0 (this device)	K082194	Laurimed Percutaneous Discectomy System, Model FG-000002	Laurimed, LLC	2008	—
+1	K090815	Percutaneous Discectomy System	Laurimed, LLC	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

FIG. 1 — Lineage of K082194, 1991–2009Source: 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.

Planning a device in HRX? 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 HRX device

#1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · 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? (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	Applicant	Decided	Recalls
*	K923525	Nucleotome 3.5 MM Automated Percutaneous Lumbar Summary page 1 …Laurimed Percutaneous Discectomy System is substantially equivalent to Surgical Dynamics, Inc. Nucleotome 3.5mm Automated Percutaneous Lumbar Discectomy Kit (K923525) and Nucleotome II (Version 2) Tissue Aspirator/Cutter(K914282). F. Device Description The Laurimed Percutaneous…	Surgical Dynamics, Inc.	1993	—
*	K914282	Nucleotome (R) II (VERSION2) Tissue Aspira/Cutter Summary page 1 …o Surgical Dynamics, Inc. Nucleotome 3.5mm Automated Percutaneous Lumbar Discectomy Kit (K923525) and Nucleotome II (Version 2) Tissue Aspirator/Cutter(K914282). F. Device Description The Laurimed Percutaneous Discectomy System is intended to be used to cut and aspirate nu…	Surgical Dynamics, Inc.	1991	—

Also cleared against K923525: 3 other devices →

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
K090815	Percutaneous Discectomy System	Laurimed, LLC	2009	0

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?

None of the 2 ancestors has a recall.
Of its descendants, K090815 (Laurimed, LLC, 2009) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K923525.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · HRX

9in 2025

2007high 12 (2013) · low 3 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRX

107in 2025

2007high 249 (2023) · low 45 (2019)2026

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

Recalls per year · HRX

1in 2024

2007high 23 (2009) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRX

2,076in 2025

2007high 2,427 (2024) · low 421 (2007)2025

MAUDE reports naming product code HRX, 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	7	89	3	421
2008	9	115	13	441
2009	11	139	23	558
2010	9	114	12	612
2011	3	84	6	631
2012	11	102	0	778
2013	12	90	4	678
2014	9	140	0	802
2015	4	132	7	763
2016	8	89	0	469
2017	4	97	0	934
2018	12	101	1	1,581
2019	12	45	0	1,676
2020	7	141	0	1,706
2021	7	57	3	1,908
2022	3	89	0	1,406
2023	4	249	0	1,852
2024	6	110	1	2,427
2025	9	107	0	2,076
2026	7	217	0	—

What is it indicated for?

The Laurimed Percutaneous Discectomy System is indicated for use in aspiration of disc material during percutaneous discectomies in the lumbar region of the spine.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082194 · printed Nov 4, 2026

Cite this page

510(k) Report. “K082194: Laurimed Percutaneous Discectomy System, Model FG-000002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082194

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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