510(k) · Cleared

Cleared

Electrosurgical Unit 774

K850668510(k) TraditionalCleared May 20, 198589-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

Birtcher Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on May 20, 1985 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1,030 later devices descend from it.

Decided: May 20, 1985
Review: 89 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 0

1,030 later devices descend from it, 1 citing it directly.

This deviceK850668 Electrosurgical Unit 774Birtcher Corp. · 1985
Descendant · cites it directly · 1,029 of its ownK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
Descendant · 2 generations on · 977 of its ownK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
Descendant · 3 generations on · 973 of its ownK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
Descendant · 3 generations on · 714 of its ownK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
Descendant · 4 generations on · 705 of its ownK022266 Aurora SRSyneron Medical, Ltd. · 2002

Showing 5 of 1,030 descendants. See all descendants

Descendants cleared per year

1997high 132 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 1,030 · See all

K971532Arthrocare Electrosurgery SystemArthrocare Corp. · 1997 · cites it directly1,029descendants
K974521Vnus Closure SystemVnus Medical Technologies, Inc. · 1998 · 2 generations on977descendants
K982816Vnus Closure SystemVnus Medical Technologies, Inc. · 1999 · 3 generations on973descendants
K012398Diomed 15 Diode LaserDiomed, Ltd. · 2002 · 3 generations on714descendants
K022266Aurora SRSyneron Medical, Ltd. · 2002 · 4 generations on705descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K850668	Electrosurgical Unit 774	Birtcher Corp.	1985	—
+1	K971532	Arthrocare Electrosurgery System	Arthrocare Corp.	1997	—
+2	K974521	Vnus Closure System	Vnus Medical Technologies, Inc.	1998	—
+3	K982816	Vnus Closure System	Vnus Medical Technologies, Inc.	1999	—
+3	K012398	Diomed 15 Diode Laser	Diomed, Ltd.	2002	—
+4	K022266	Aurora SR	Syneron Medical, Ltd.	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0
1999	2	0
2001	2	0
2002	8	0
2003	12	0
2004	10	0
2005	13	0
2006	14	0
2007	13	0
2008	28	0
2009	23	0
2010	30	0
2011	20	0
2012	21	0
2013	27	0
2014	39	0
2015	37	0
2016	52	0
2017	54	0
2018	50	0
2019	37	0
2020	48	0
2021	50	0
2022	70	0
2023	66	0
2024	94	0
2025	132	0
2026	76	0

FIG. 1 — Lineage of K850668, 1985–2026Source: 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 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?

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

What descends from it? (1,030)

See all 1,030

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K971532	Arthrocare Electrosurgery System	Arthrocare Corp.	1997	1,029

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?

Of its descendants, K971532 (Arthrocare Corp., 1997) has gone furthest, with 1,029 descendants of its own.

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	—

https://510kreport.com/device/K850668 · printed Nov 3, 2026

Cite this page

510(k) Report. “K850668: Electrosurgical Unit 774.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K850668

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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