510(k) · Cleared

Cleared

Olympus PSD-20 Electrosurgical System & Its Associated Accessories

K021852510(k) TraditionalCleared Feb 11, 2003251-day reviewClass II21 CFR 878.4400

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

Olympus Optical Co., Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Feb 11, 2003 as substantially equivalent to K970797 (Olympus America, Inc., 1997) after a 251-day review. Its family tree reaches back 2 generations to 1991.

Decided: Feb 11, 2003
Review: 251 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K911904 (1991). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK911904 Models Ues-10 & PSD-10Olympus Corp. · 1991
1 generation backK970797 Olympus PSD-20 Electrosurgical System and AccessoriesOlympus America, Inc. · 1997
This deviceK021852 Olympus PSD-20 Electrosurgical System & Its Associated AccessoriesOlympus Optical Co., Ltd. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K911904	Models Ues-10 & PSD-10	Olympus Corp.	1991	—
−1	K970797	Olympus PSD-20 Electrosurgical System and Accessories	Olympus America, Inc.	1997	—
0 (this device)	K021852	Olympus PSD-20 Electrosurgical System & Its Associated Accessories	Olympus Optical Co., Ltd.	2003	—

FIG. 1 — Lineage of K021852, 1991–2003Source: 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 GEI? 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 GEI device

#1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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? (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
*	K970797	Olympus PSD-20 Electrosurgical System and Accessories Summary page 1 …cteristics or specifications. Model Name I 51O(k) ADDIican t Olympus PSD-20 Eledrosurgical K970797 Olympus Optical Co.,Ltd. Unit and its associated accessories (For GI application ) D. Device Description 1…	Olympus America, Inc.	1997	—

Also cleared against K970797: 1 other device →

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?

The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K970797.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, 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	50	51	21	2,795
2008	61	71	19	2,556
2009	42	130	27	3,591
2010	46	109	51	3,377
2011	35	135	32	4,463
2012	39	133	30	5,216
2013	48	136	13	4,897
2014	49	103	3	4,908
2015	47	123	4	4,936
2016	64	108	3	5,616
2017	52	72	2	6,073
2018	47	93	6	6,545
2019	48	93	5	7,067
2020	59	105	1	6,490
2021	46	146	6	6,354
2022	55	150	49	6,103
2023	65	104	27 (4)	7,176
2024	59	125	22 (10)	7,897
2025	52	113	4	7,592
2026	43	183	8	—

What is it indicated for?

This instrument has been designed to be used with Olympus recommended

Electrosurgical accessories, Endoscope, Light Source and other ancillary equipment

for bronchial endoscopic treatment (cutting and coagulating) including;

Hemostasis of superficial bleeding

Treatment of benign tumors like papillomatosis, granulomas, polyps, lipomas and

hemangiomas in the trachea and bronchi

Recanalization of malignant stenoses

Treatment of Cicatricial stenoses of the respiratory tract

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021852 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021852: Olympus PSD-20 Electrosurgical System & Its Associated Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021852

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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