510(k) · Cleared
ClearedReusable Monopolar Active Cord
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Us Endoscopy · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 25, 2019 as substantially equivalent to K982748 (New Deantronics Taiwan, Ltd., 1998) after a 42-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Oct 25, 2019
- Review
- 42 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K982748 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK982748 BI-Polar Cord Set 1.88 TR, BI-Polar Cord Set 1.83 TR, Model #'S…New Deantronics Taiwan, Ltd. · 1998
- This deviceK192518 Reusable Monopolar Active CordUs Endoscopy · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K982748 | BI-Polar Cord Set 1.88 TR, BI-Polar Cord Set 1.83 TR, Model #'S SB223, SB 224 | New Deantronics Taiwan, Ltd. | 1998 | — |
| 0 (this device) | K192518 | Reusable Monopolar Active Cord | Us Endoscopy | 2019 | — |
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 |
|---|---|---|---|
| * | K982748 | BI-Polar Cord Set 1.88 TR, BI-Polar Cord Set 1.83 TR, Model #'S SB223, SB 224Summary page 5…Accessories Classification Number: 21 CFR 878.4400 Product Code: GEI 2. Predicate Device K982748 New Deantronics, Inc. Model SB 223 and SB 224 BiPolar Cord Sets 3. Description of Device The Reusable Monopolar… | 1998 |
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?
- Its one ancestor has no 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. 2019, 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 Reusable Monopolar Active Cord is intended to deliver monopolar electrical current from the electrosurgical unit to electrosurgical devices or accessories requiring monopolar electrical current during endoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192518 · printed Nov 3, 2026
Cite this page
510(k) Report. “K192518: Reusable Monopolar Active Cord.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K192518
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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