510(k) · Cleared

Cleared

PK Superpulse Sysem Generator Model 744000

K100816510(k) TraditionalCleared Jul 1, 2010100-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

Gyrus Acmi, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jul 1, 2010 as substantially equivalent to K031085 (Gyrus Medical, Inc., 2003) and 2 other predicates after a 100-day review. Its family tree reaches back 4 generations to 1991. 22 later devices descend from it.

Decided: Jul 1, 2010
Review: 100 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to K911904 (1991). 15 ancestors in all. 22 later devices descend from it, 3 citing it directly.

By dateBy generation

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 deviceK100816 PK Superpulse Sysem Generator Model 744000Gyrus Acmi, Inc. · 2010
Descendant · cites it directly · 16 of its ownK110268 Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2011
Descendant · 2 generations on · 10 of its ownK151649 Valleylab FT10 Electrosurgical PlatformCovidien · 2015
Descendant · 3 generations on · 8 of its ownK170170 Valleylab FT10 Electrosurgical PlatformCovidien, LLC · 2017
Descendant · 3 generations on · 6 of its ownK172757 Valleylab FX8 Electrosurgical PlatformCovidien, LLC · 2017
Descendant · 4 generations on · 5 of its ownK181389 Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy…Covidien · 2018

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2011high 4 (2022) · low 0 (2013)2026

Most influential descendants

Showing 5 of 22 · See all

K110268Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2011 · cites it directly16descendants
K151649Valleylab FT10 Electrosurgical PlatformCovidien · 2015 · 2 generations on10descendants
K170170Valleylab FT10 Electrosurgical PlatformCovidien, LLC · 2017 · 3 generations on8descendants
K172757Valleylab FX8 Electrosurgical PlatformCovidien, LLC · 2017 · 3 generations on6descendants
K181389Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy PlatformCovidien · 2018 · 4 generations on5descendants

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)	K100816	PK Superpulse Sysem Generator Model 744000	Gyrus Acmi, Inc.	2010	—
+1	K110268	Forcetriad Electrosurgical Generator	Covidien Lp, Formerly Know AS Valleylab, A Divison	2011	—
+2	K151649	Valleylab FT10 Electrosurgical Platform	Covidien	2015	—
+3	K170170	Valleylab FT10 Electrosurgical Platform	Covidien, LLC	2017	—
+3	K172757	Valleylab FX8 Electrosurgical Platform	Covidien, LLC	2017	—
+4	K181389	Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform	Covidien	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1996	1	0
1997	1	0
1999	3	0
2000	3	0
2003	1	0
2008	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	1	0
2015	2	0
2017	3	0
2018	2	0
2019	1	0
2022	4	0
2023	1	0
2024	4	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K100816, 1991–2026Source: 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

Get a 510(k) Report

What was it cleared against? (3)

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
*	K031085	Gyrus Plasmakinetic Superpulse System (Generator, Accessories) Summary page 2 …March 19, 2010 Southborough, MA 01772 Predicate Devices Gyrus PlasmaKineticTm SuperPulse® System K03 1085 Olympus XUES-41 Electrosurgical Unit and accessories K030194 Gyrus ACM! PK® SuperPulse® System…	Gyrus Medical, Inc.	2003	—
*	K030194	Xues-41 Endoscopic Electrosurgical Unit Summary page 2 …yrus PlasmaKineticTm SuperPulse® System K03 1085 Olympus XUES-41 Electrosurgical Unit and accessories K030194 Gyrus ACM! PK® SuperPulse® System K082054 Intended Use The Cyrus ACMI PK® Superpu…	The Olympus Optical Co.	2003	3
*	K082054	Gyrus Acmi Plasmakinetic (PK) Superpulse System, Model 744000 and Dual Footswitch… Summary page 2 …Olympus XUES-41 Electrosurgical Unit and accessories K030194 Gyrus ACM! PK® SuperPulse® System K082054 Intended Use The Cyrus ACMI PK® Superpulseg System Generator is intended for use with Cyrus ACM! PK® Bipolar Instruments, Olympu…	Gyrus Acmi, Inc.	2008	—

Also cleared against K031085: 6 other devices →

What descends from it? (22)

See all 22

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

Number	Device	Applicant	Decided	Descendants
K110268	Forcetriad Electrosurgical Generator	Covidien Lp, Formerly Know AS Valleylab, A Divison	2011	16
K120567	Gyrus Amci PK Button Electrode	Gyrus Acmi, Inc.	2012	3
K222542	MCB UNIT Model: V10GMCBUS	Lamidey Noury Medical	2022	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?

The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
2 of the 15 ancestors have a recall of any class.
Of its descendants, K110268 (Covidien Lp, Formerly Know AS Valleylab, A Divison, 2011) has gone furthest, with 16 descendants of its own.
6 other devices also cite its predicate K031085.

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. 2010, this device’s year, is highlighted.

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?

The Gyrus ACMI PK® Superpulse® System is intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.

The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K100816 · printed Nov 5, 2026

Cite this page

510(k) Report. “K100816: PK Superpulse Sysem Generator Model 744000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K100816

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