510(k) · Cleared

Cleared

Wandy Dispersvie Electrode

K121268510(k) TraditionalCleared Dec 20, 2012238-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

Bio-Med USA, Inc. · ODR Electrosurgical Patient Return Electrode

Cleared on Dec 20, 2012 as substantially equivalent to K100686 (Conmed Corporation, 2010) after a 238-day review. Its family tree reaches back 2 generations to 1995.

Decided: Dec 20, 2012
Review: 238 days
Class: Class II
Product code: ODR
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K954633 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK954633 Conmed Electrosurgical Grounding PadConmedcorp · 1995
1 generation backK100686 Conmed Macrolyte Dispersive ElectrodeConmed Corporation · 2010
This deviceK121268 Wandy Dispersvie ElectrodeBio-Med USA, Inc. · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K954633	Conmed Electrosurgical Grounding Pad	Conmedcorp	1995	—
−1	K100686	Conmed Macrolyte Dispersive Electrode	Conmed Corporation	2010	—
0 (this device)	K121268	Wandy Dispersvie Electrode	Bio-Med USA, Inc.	2012	—

FIG. 1 — Lineage of K121268, 1995–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 ODR? 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? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K100686	Conmed Macrolyte Dispersive Electrode Summary page 1 …ing Pad Regulation : 878.4400 Class 11 Product Code : ODR 4. Legally marketed Predicate Device K100686 Conmed Corp Macrolyte Dispersive Electrode 5. Device Description Wandy Dispersive Electrode is design…	Conmed Corporation	2010	—

Also cleared against K100686: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 14.6 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K100686.

How does its category compare?

All ODR devices

ODR Electrosurgical Patient Return Electrode: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · ODR

1in 2016

2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODR

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

Recalls per year · ODR

No recall names ODR since 2007.

Adverse event reports per year · ODR

1in 2017

2007high 118 (2009) · low 0 (2015)2025

MAUDE reports naming product code ODR, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	3
2008	1	—	94
2009	0	—	118
2010	0	—	23
2011	0	—	6
2012	1	—	4
2013	0	—	6
2014	0	—	4
2015	0	—	0
2016	1	—	2
2017	0	—	1
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

Wandy's Dispersive Electrode is intended use to the patient during Electrosurgical procedures to provide a path for RF current to leave the patient and return to the Generator

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121268 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121268: Wandy Dispersvie Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121268

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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