510(k) · Cleared

Recalled · Class II · 2013

Hyfrecator, #733

K800617510(k) TraditionalCleared May 2, 198045-day reviewClass II21 CFR 878.4400Recalls 4

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 2, 1980 after a 45-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1,325 later devices descend from it. It has been recalled 4 times.

Decided: May 2, 1980
Review: 45 days
Class: Class II
Product code: GEI
Recalls: 4
Predicates: 0

1,325 later devices descend from it, 5 citing it directly.

This deviceK800617 Hyfrecator, #733Birtcher Corp. · 1980
Descendant · cites it directly · 1,322 of its ownK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
Descendant · 2 generations on · 1,219 of its ownK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
Descendant · cites it directly · 1,073 of its ownK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
Descendant · 2 generations on · 1,069 of its ownK000944 Thermage Thermacool SystemThermage, Inc. · 2000
Descendant · cites it directly · 1,029 of its ownK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997

Showing 5 of 1,325 descendants. See all descendants

Descendants cleared per year

1997high 136 (2025) · low 2 (1997)2026

Most influential descendants

Showing 5 of 1,325 · See all

K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997 · cites it directly1,322descendants
K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998 · 2 generations on1,219descendants
K981870Visage Cosmetic Surgery SystemArthrocare Corp. · 1998 · cites it directly1,073descendants
K000944Thermage Thermacool SystemThermage, Inc. · 2000 · 2 generations on1,069descendants
K971532Arthrocare Electrosurgery SystemArthrocare Corp. · 1997 · cites it directly1,029descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K800617	Hyfrecator, #733	Birtcher Corp.	1980	—
+1	K964849	Arthrocare Dermatologic Electrosurgery System	Arthrocare Corp.	1997	—
+2	K973478	Arthrocare Sinus Electrosurgery System	Arthrocare Corp.	1998	—
+1	K981870	Visage Cosmetic Surgery System	Arthrocare Corp.	1998	—
+2	K000944	Thermage Thermacool System	Thermage, Inc.	2000	—
+1	K971532	Arthrocare Electrosurgery System	Arthrocare Corp.	1997	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	2	0
1998	3	0
1999	4	0
2000	2	0
2001	5	0
2002	14	0
2003	23	0
2004	16	0
2005	20	0
2006	18	0
2007	22	0
2008	44	0
2009	31	0
2010	40	0
2011	28	0
2012	35	0
2013	47	0
2014	48	0
2015	56	0
2016	73	0
2017	69	0
2018	59	0
2019	49	0
2020	62	0
2021	68	0
2022	85	0
2023	81	0
2024	101	0
2025	136	0
2026	84	0

FIG. 1 — Lineage of K800617, 1980–2026Source: 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

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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? (1,325)

See all 1,325

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

Number	Device	Applicant	Decided	Descendants
K964849	Arthrocare Dermatologic Electrosurgery System	Arthrocare Corp.	1997	1,322
K981870	Visage Cosmetic Surgery System	Arthrocare Corp.	1998	1,073
K971532	Arthrocare Electrosurgery System	Arthrocare Corp.	1997	1,029
K063748	Thermomed 1.8	Thermosurgery Technologies, Inc.	2007	0
K983852	Blue Value Line of Electrosurgical Electrodes, Model #'S 421-429	Geiger Medical Technologies, Inc.	1999	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 28, 2013	Class II	Z-0826-2013	Equipment maintenance	Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.
Jan 28, 2013	Class II	Z-0827-2013	Equipment maintenance	Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.
Dec 27, 2012	Class II	Z-0718-2013	Equipment maintenance	ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed…
Dec 27, 2012	Class II	Z-0719-2013	Equipment maintenance	ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K964849 (Arthrocare Corp., 1997) has gone furthest, with 1,322 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/K800617 · printed Nov 6, 2026

Cite this page

510(k) Report. “K800617: Hyfrecator, #733.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K800617

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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