510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Radionics Single Use Ground Pad (DGP-HP)

K030697510(k) SpecialCleared Apr 4, 200329-day reviewClass II21 CFR 878.4400Recalls 1

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

Radionics, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Apr 4, 2003 as substantially equivalent to K923647 (Radionics, Inc., 1992) and 1 other predicate after a 29-day review. Its family tree reaches back 1 generation to 1992. It has been recalled once.

Decided
Apr 4, 2003
Review
29 days
Class
Class II
Product code
GEI
Recalls
1
Predicates
2

Its longest line of descent runs back 1 generation to K923647 (1992). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestorK923647 · RFG-DGP Disposable Grounding Pads · Radionics, Inc. · 19921990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor K923647 · RFG-DGP Disposable Grounding Pads · Radionics, Inc. · 19920
  1. Root · 1 generation backK923647 RFG-DGP Disposable Grounding PadsRadionics, Inc. · 1992
  2. This deviceK030697 Radionics Single Use Ground Pad (DGP-HP)Radionics, Inc. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K923647RFG-DGP Disposable Grounding PadsRadionics, Inc.1992—
0 (this device)K030697Radionics Single Use Ground Pad (DGP-HP)Radionics, Inc.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
FIG. 1 — Lineage of K030697, 1992–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K923647RFG-DGP Disposable Grounding Pads
Summary page 1
…al Coagulation Device Accessory. 3.0 The above device is substantial equivalent to the Radionics RFG-DGP Disposable Grounding Pad that was cleared via 5 lO(k), K923647, on November 9, and the Nikopad Electrosurgical Grounding Pad Model 4777M that was cleared via 5 1O(k), K000079, on Febru…
Radionics, Inc.1992—
*K000079Nikopad Electrosurgical Grounding Pad, Model 4777M
Summary page 1
…e Grounding Pad that was cleared via 5 lO(k), K923647, on November 9, and the Nikopad Electrosurgical Grounding Pad Model 4777M that was cleared via 5 1O(k), K000079, on February 4,2000. 4.0 The Radionics Disposable Grounding Pad, DGP-HP, is a dispersive electrode that self adheres to the…
Nikomed U.S.A., Inc.20002

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 1, 2012Class IIZ-2301-2012Process controlCovidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads and Cool-tip RFA Electrode Kits due to the potential for foil degradation on the DGP-HP single use grounding pad which may result…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 2 ancestors has a recall of any class.

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

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
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

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

The Radionics DGP-HP Single Use Ground Pad is to be used with the Radionics Cool-tipTM RF System.

Indications for use as stated in the FDA summary.

More from Radionics, Inc.

56 FDA decisions under this applicant name. See the company

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  • K001950Optical Tracking System (Ots)Radionics, Inc. · 2000
  • K001700XPLAN 2.1Radionics, Inc. · 2000

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https://510kreport.com/device/K030697 · printed Nov 3, 2026

Cite this page

510(k) Report. “K030697: Radionics Single Use Ground Pad (DGP-HP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030697

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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