510(k) · Decided

Recalled · Class II · 2021

Clarus Models 1100, 1101, 1102, 1103 Laser Disc

K922881510(k) TraditionalDecided Nov 16, 1992153-day reviewClass II21 CFR 878.4810Recalls 1

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

Clarus Medical Systems, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Nov 16, 1992 after a 153-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 21 later devices descend from it. It has been recalled once.

Decided: Nov 16, 1992
Review: 153 days
Class: Class II
Product code: GEX
Recalls: 1
Predicates: 0

21 later devices descend from it, 3 citing it directly.

This deviceK922881 Clarus Models 1100, 1101, 1102, 1103 Laser DiscClarus Medical Systems, Inc. · 1992
Descendant · cites it directly · 19 of its ownK022610 Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing…Clarus Medical, LLC · 2002
Descendant · cites it directly · 18 of its ownK040424 Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous…Clarus Medical, LLC · 2004 · Recalled
Descendant · 2 generations on · 17 of its ownK040919 Nucleotome Probe Set, Model 21200Clarus Medical, LLC · 2004 · Recalled
Descendant · 3 generations on · 14 of its ownK062038 X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006
Descendant · 4 generations on · 13 of its ownK093062 Vertos Medical Mild Device KitX-Sten Corp. · 2010

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2002high 4 (2026) · low 0 (2003)2026

Most influential descendants

Showing 5 of 21 · See all

K022610Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser Fiber, Model 1160Clarus Medical, LLC · 2002 · cites it directly19descendants
K040424Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy Kit, Model…Clarus Medical, LLC · 2004 · cites it directly18descendants
K040919Nucleotome Probe Set, Model 21200Clarus Medical, LLC · 2004 · 2 generations on17descendants
K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006 · 3 generations on14descendants
K093062Vertos Medical Mild Device KitX-Sten Corp. · 2010 · 4 generations on13descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K922881	Clarus Models 1100, 1101, 1102, 1103 Laser Disc	Clarus Medical Systems, Inc.	1992	—
+1	K022610	Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser…	Clarus Medical, LLC	2002	—
+1	K040424	Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy…	Clarus Medical, LLC	2004	1
+2	K040919	Nucleotome Probe Set, Model 21200	Clarus Medical, LLC	2004	1
+3	K062038	X-Sten Mild Tool Kit, Model MTK-0001	X-Sten Corp.	2006	—
+4	K093062	Vertos Medical Mild Device Kit	X-Sten Corp.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2004	2	0
2006	1	0
2009	2	0
2010	1	0
2012	1	0
2018	1	0
2019	1	0
2021	1	0
2024	2	0
2025	3	0
2026	4	0

FIG. 1 — Lineage of K922881, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEX? 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 GEX device

#1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (21)

See all 21

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K022610	Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser Fiber, Model 1160	Clarus Medical, LLC	2002	19
K040424	Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy Kit, Model…	Clarus Medical, LLC	2004	18
K021848	Clarus Straight Firing Laser Fiber; Clarus Side Firing Laser Fiber; Models 1150, 1160	Clarus Medical, LLC	2002	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 27, 2021	Class II	Z-2405-2021	Packaging process control	The sterile barrier seal may be compromised.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K022610 (Clarus Medical, LLC, 2002) has gone furthest, with 19 descendants of its own.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEX

83in 2025

2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007high 152 (2022) · low 78 (2018)2026

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

Recalls per year · GEX

3in 2024

2007high 18 (2011) · low 0 (2009)2026

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

Adverse event reports per year · GEX

2,720in 2025

2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, 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	73	79	9	342
2008	107	86	2	232
2009	69	100	0	209
2010	50	96	4	1,711
2011	41	83	18	3,024
2012	45	118	5	2,000
2013	46	144	3	2,236
2014	61	147	6	2,036
2015	47	112	0	2,099
2016	51	114	1	2,585
2017	67	90	5 (1)	2,977
2018	51	78	5	3,525
2019	41	88	6	2,709
2020	52	90	1	2,183
2021	53	123	0	3,465
2022	60	152	0	2,288
2023	52	87	6	2,337
2024	82	90	3	2,187
2025	83	90	0	2,720
2026	57	90	2	—

https://510kreport.com/device/K922881 · printed Nov 6, 2026

Cite this page

510(k) Report. “K922881: Clarus Models 1100, 1101, 1102, 1103 Laser Disc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922881

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026