510(k) · Cleared
ClearedPSD-60/Endoplasma
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Shirakawa Co., Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Feb 22, 2005 as substantially equivalent to K023886 (Erbe USA, Inc., 2002) and 4 other predicates after a 183-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Feb 22, 2005
- Review
- 183 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K911904 (1991). 15 ancestors in all, the oldest K894762 (1989). No later device cites it as a predicate yet.
- Root · 4 generations backK911904 Models Ues-10 & PSD-10Olympus Corp. · 1991
- 3 generations backK970184 Olympus Ues-20 Electrosurgical System and Its Associated AccessoriesOlympus America, Inc. · 1997
- 2 generations backK023767 Ues-30 Electrosurgical Unit and It's Associated AccessoriesThe Olympus Optical Co. · 2002
- 1 generation backK030194 Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. · 2003 · Recalled
- This deviceK042274 PSD-60/EndoplasmaOlympus Shirakawa Co., Ltd. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911904 | Models Ues-10 & PSD-10 | Olympus Corp. | 1991 | — |
| −3 | K970184 | Olympus Ues-20 Electrosurgical System and Its Associated Accessories | Olympus America, Inc. | 1997 | — |
| −2 | K023767 | Ues-30 Electrosurgical Unit and It's Associated Accessories | The Olympus Optical Co. | 2002 | — |
| −1 | K030194 | Xues-41 Endoscopic Electrosurgical Unit | The Olympus Optical Co. | 2003 | 3 |
| 0 (this device) | K042274 | PSD-60/Endoplasma | Olympus Shirakawa Co., Ltd. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 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.
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
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K023886 | Erbe Vio Esu with Accessories, Model Vio 300 DSummary page 2…ing table shows regulatory history. Model 510(k)# Manufacturer Class P-Code ERBE VIO ESU, Model VIO300D #k023886 ERBE Elektromedizin II GEl GmbH UES-20 Electrosurgi… | 2002 |
| * | K970184 | Olympus Ues-20 Electrosurgical System and Its Associated AccessoriesSummary page 2…VIO300D #k023886 ERBE Elektromedizin II GEl GmbH UES-20 Electrosurgical System #k970184 OLYMPUS II GEl and associated Accessories XUES-41 Endoscopic #k030194… | 1997 |
| * | K030194 | Xues-41 Endoscopic Electrosurgical UnitSummary page 2…GmbH UES-20 Electrosurgical System #k970184 OLYMPUS II GEl and associated Accessories XUES-41 Endoscopic #k030194 OLYMPUS I KNS Electrosurgical unit ERBE VIO APC, Model APC-2 #k024047 ERBE E… | 2003 |
| * | K024047 | Erbe Vio Apc with AccessoriesSummary page 2…ed Accessories XUES-41 Endoscopic #k030194 OLYMPUS I KNS Electrosurgical unit ERBE VIO APC, Model APC-2 #k024047 ERBE Elektromedizin ]I GEl GmbH D. DEVICE DESCRIPTION… | 2003 |
| * | K963189 | Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and…Summary page 4…frequency energy. This system is equivalent to the predicate devices, ERBE V103000 (K023886), OLYMPUS UES-20 (K970184), ERBE VIO APC2 (K024047) and ERBE APC300 (K963189). F. CONCLUSION When compared to the predicate devices, PSD-60and ENDOPLASMA do not incorporate any significant changes i… | 1996 |
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 14 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 2 of the 15 ancestors have a recall of any class.
- 8 other devices also cite its predicate K023886.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 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?
The PSD-60 has been designed to be used with OLYMPUS endoscope (fiberscope, videoscope and rigid scope) compatible with electrosurgical accessories and other ancillary equipment for general, laparoscopic and endoscopic electrosurgery (cutting, coagulation, including soft tissue coagulation).
The argon plasma coagulation unit has been designed to be used with the electrosurgical unit, OLYMPUS PSD-60 for argon plasma coagulation (APC) of living tissues in treatment using OLYMPUS endoscope compatible with electrosurgery, argon plasma coagulation accessories and other ancillary equipment for endoscopic electrosurgery (coagulation).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042274 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042274: PSD-60/Endoplasma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042274
Report an extraction error
Are you the manufacturer?
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