510(k) · Cleared

Recalled · 2003

Nikopad Electrosurgical Grounding Pad, Model 4777M

K000079510(k) SpecialCleared Feb 4, 200024-day reviewClass II21 CFR 878.4400Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nikomed U.S.A., Inc. · HAM Apparatus, Electrosurgical

Cleared on Feb 4, 2000 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 801 later devices descend from it. It has been recalled 2 times.

Decided: Feb 4, 2000
Review: 24 days
Class: Class II
Product code: HAM
Recalls: 2
Predicates: 0

801 later devices descend from it, 3 citing it directly.

This deviceK000079 Nikopad Electrosurgical Grounding Pad, Model 4777MNikomed U.S.A., Inc. · 2000
Descendant · cites it directly · 799 of its ownK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
Descendant · cites it directly · 789 of its ownK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
Descendant · 2 generations on · 773 of its ownK030142 Thermacool TC SystemThermage, Inc. · 2003
Descendant · 3 generations on · 678 of its ownK031671 Polaris WRSyneron Medical, Ltd. · 2003
Descendant · 2 generations on · 527 of its ownK033942 Thermage Thermacool SystemThermage, Inc. · 2004

Showing 5 of 801 descendants. See all descendants

Descendants cleared per year

2002high 90 (2025) · low 2 (2002)2026

Most influential descendants

Showing 5 of 801 · See all

K013639Thermage Thermacool TC SystemThermage, Inc. · 2002 · cites it directly799descendants
K021402Thermage Thermacool TC SystemThermage, Inc. · 2002 · cites it directly789descendants
K030142Thermacool TC SystemThermage, Inc. · 2003 · 2 generations on773descendants
K031671Polaris WRSyneron Medical, Ltd. · 2003 · 3 generations on678descendants
K033942Thermage Thermacool SystemThermage, Inc. · 2004 · 2 generations on527descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K000079	Nikopad Electrosurgical Grounding Pad, Model 4777M	Nikomed U.S.A., Inc.	2000	—
+1	K013639	Thermage Thermacool TC System	Thermage, Inc.	2002	—
+1	K021402	Thermage Thermacool TC System	Thermage, Inc.	2002	—
+2	K030142	Thermacool TC System	Thermage, Inc.	2003	—
+3	K031671	Polaris WR	Syneron Medical, Ltd.	2003	—
+2	K033942	Thermage Thermacool System	Thermage, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2003	6	0
2004	3	0
2005	5	0
2006	6	0
2007	13	0
2008	24	0
2009	20	0
2010	21	0
2011	15	0
2012	19	0
2013	28	0
2014	31	0
2015	32	0
2016	46	0
2017	42	0
2018	36	0
2019	30	0
2020	46	0
2021	42	0
2022	60	0
2023	51	0
2024	78	0
2025	90	0
2026	55	0

FIG. 1 — Lineage of K000079, 2000–2026Source: 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 HAM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin 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? (801)

See all 801

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

Number	Device	Applicant	Decided	Descendants
K013639	Thermage Thermacool TC System	Thermage, Inc.	2002	799
K021402	Thermage Thermacool TC System	Thermage, Inc.	2002	789
K030697	Radionics Single Use Ground Pad (DGP-HP)	Radionics, Inc.	2003	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 16, 2003	Not classified	Z-1122-03	Other	Pads may have a thin plastic film covering the conductive gel surface underneath the normal printed cover, causing non-adherence and possible burn.
Jul 16, 2003	Not classified	Z-1121-03	Other	Pads may have a thin plastic film covering the conductive gel surface underneath the normal printed cover, causing non-adherence and possible burn.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K013639 (Thermage, Inc., 2002) has gone furthest, with 799 descendants of its own.

How does its category compare?

All HAM devices

HAM Apparatus, Electrosurgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HAM

1in 2016

2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HAM

Too few HAM 510(k)s in any year since 2007 to give a median.

Recalls per year · HAM

1in 2012

2007high 1 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HAM

2in 2025

2007high 11 (2019) · low 0 (2007)2025

MAUDE reports naming product code HAM, 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	0	—	0	0
2008	0	—	0	0
2009	0	—	0	1
2010	0	—	0	1
2011	0	—	0	0
2012	0	—	1	1
2013	0	—	0	1
2014	0	—	0	0
2015	0	—	0	1
2016	1	—	0	3
2017	0	—	0	3
2018	0	—	0	6
2019	0	—	0	11
2020	0	—	0	3
2021	0	—	0	1
2022	0	—	0	0
2023	0	—	0	3
2024	0	—	0	1
2025	0	—	0	2
2026	0	—	0	—

https://510kreport.com/device/K000079 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000079: Nikopad Electrosurgical Grounding Pad, Model 4777M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000079

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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