510(k) · Cleared

Cleared

Arco-MBC, Arco MC

K954171510(k) TraditionalCleared Apr 30, 1996238-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

Holl Meditronics, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Apr 30, 1996 after a 238-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 29 later devices descend from it.

Decided: Apr 30, 1996
Review: 238 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 0

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

This deviceK954171 Arco-MBC, Arco MCHoll Meditronics, Inc. · 1996
Descendant · cites it directly · 28 of its ownK993265 Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600Soring GmbH Medizintechnik · 1999
Descendant · 2 generations on · 26 of its ownK024059 MBC SeriesSoring GmbH Medizintechnik · 2003
Descendant · 3 generations on · 24 of its ownK052859 Aquamantys Pump Generator SystemTissuelink Medical, Inc. · 2005 · Recalled
Descendant · 4 generations on · 7 of its ownK063639 Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1Tissuelink Medical, Inc. · 2007
Descendant · 4 generations on · 5 of its ownK111732 Aquamantys SBS 5.0 Sheated Biopolar SealerSalient Surgical Technologies, Inc. · 2011

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

1999high 3 (2011) · low 0 (2000)2026

Most influential descendants

Showing 5 of 29 · See all

K993265Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600Soring GmbH Medizintechnik · 1999 · cites it directly28descendants
K024059MBC SeriesSoring GmbH Medizintechnik · 2003 · 2 generations on26descendants
K052859Aquamantys Pump Generator SystemTissuelink Medical, Inc. · 2005 · 3 generations on24descendants
K063639Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1Tissuelink Medical, Inc. · 2007 · 4 generations on7descendants
K111732Aquamantys SBS 5.0 Sheated Biopolar SealerSalient Surgical Technologies, Inc. · 2011 · 4 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K954171	Arco-MBC, Arco MC	Holl Meditronics, Inc.	1996	—
+1	K993265	Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600	Soring GmbH Medizintechnik	1999	—
+2	K024059	MBC Series	Soring GmbH Medizintechnik	2003	—
+3	K052859	Aquamantys Pump Generator System	Tissuelink Medical, Inc.	2005	1
+4	K063639	Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1	Tissuelink Medical, Inc.	2007	—
+4	K111732	Aquamantys SBS 5.0 Sheated Biopolar Sealer	Salient Surgical Technologies, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2003	2	0
2005	1	0
2007	1	0
2008	1	0
2010	2	0
2011	3	0
2012	2	0
2013	3	0
2014	1	0
2017	2	0
2019	2	0
2020	1	0
2021	2	0
2022	2	0
2023	3	0

FIG. 1 — Lineage of K954171, 1996–2023Source: 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (29)

See all 29

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

Number	Device	Applicant	Decided	Descendants
K993265	Soring GMBH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600	Soring GmbH Medizintechnik	1999	28

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, K993265 (Soring GmbH Medizintechnik, 1999) has gone furthest, with 28 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/K954171 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954171: Arco-MBC, Arco MC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954171

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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