510(k) · Cleared
ClearedBiPad Hand Activated, Disposable Bipolar Electrocautery Cords
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bipad Surgical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 31, 2020 as substantially equivalent to K110462 (Kepler Medtec, 2011) after a 29-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Jul 31, 2020
- Review
- 29 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K970993 (1997). No later device cites it as a predicate yet.
- Root · 2 generations backK970993 Deroyal Industries, Inc. Disposable Bipolar Electrosurgical CableDeroyal Industries, Inc. · 1997
- 1 generation backK110462 Kepler Medtec Disposable Bipolar CableKepler Medtec · 2011
- This deviceK201833 BiPad Hand Activated, Disposable Bipolar Electrocautery CordsBipad Surgical, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970993 | Deroyal Industries, Inc. Disposable Bipolar Electrosurgical Cable | Deroyal Industries, Inc. | 1997 | — |
| −1 | K110462 | Kepler Medtec Disposable Bipolar Cable | Kepler Medtec | 2011 | — |
| 0 (this device) | K201833 | BiPad Hand Activated, Disposable Bipolar Electrocautery Cords | Bipad Surgical, Inc. | 2020 | — |
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? (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 | Decided |
|---|---|---|---|
| * | K110462 | Kepler Medtec Disposable Bipolar CableSummary page 4…e Product Code, Device Panel: GEI, General & Plastic Surgery Predicate Device: Kepler MedTec Disposable Bipolar Cable (K110462) 5.1 Device Description The BiPAD® Hand Activated, Disposable Bipolar Electrocautery Cords, Model BP105-C (Codman) an… | 2011 |
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 23 years and passes through 3 companies; a new generation was cleared every 14.3 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
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 BiPAD® Hand Activated, Disposable Bipolar Electrocautery Cords are intended to connect an electrosurgical device to an electrosurgical generator. They are indicated for use with bipolar forceps during general surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201833 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201833: BiPad Hand Activated, Disposable Bipolar Electrocautery Cords.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201833
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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