510(k) · Cleared
ClearedDeroyal Industries, Inc. Disposable Bipolar Electrosurgical Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deroyal Industries, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 22, 1997 after a 64-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- May 22, 1997
- Review
- 64 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK970993 Deroyal Industries, Inc. Disposable Bipolar Electrosurgical CableDeroyal Industries, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK110462 Kepler Medtec Disposable Bipolar CableKepler Medtec · 2011
- Descendant · 2 generations on · 0 of its ownK201833 BiPad Hand Activated, Disposable Bipolar Electrocautery CordsBipad Surgical, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970993 | Deroyal Industries, Inc. Disposable Bipolar Electrosurgical Cable | Deroyal Industries, Inc. | 1997 | — |
| +1 | K110462 | Kepler Medtec Disposable Bipolar Cable | Kepler Medtec | 2011 | — |
| +2 | K201833 | BiPad Hand Activated, Disposable Bipolar Electrocautery Cords | Bipad Surgical, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2020 | 1 | 0 |
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 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
What was it cleared against? (10)
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 | Decided |
|---|---|---|---|
| * | — | American Biosurgical Named without a submission number | |
| * | — | Apple Medical Named without a submission number | |
| * | — | Birtcher Medical Systems Named without a submission number | |
| * | — | Codman Named without a submission number | |
| * | — | Conmed Named without a submission number | |
| * | — | Kirwan Named without a submission number | |
| * | — | Olsen Named without a submission number | |
| * | — | Pilling Named without a submission number | |
| * | — | Weck Named without a submission number | |
| * | — | Valleylab Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110462 | Kepler Medtec Disposable Bipolar Cable | 2011 | 1 |
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, K110462 (Kepler Medtec, 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 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 | — |
What is it indicated for?
The DeRoyal Industries, Inc. Disposable Bipolar Electrosurgical Cable is indicated for use during electrosurgical procedures to provide transmission of electrical power from an electrosurgical generator to a bipolar instrument.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970993 · printed Nov 3, 2026
Cite this page
510(k) Report. “K970993: Deroyal Industries, Inc. Disposable Bipolar Electrosurgical Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K970993
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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