510(k) · Cleared
ClearedSmith & Nephew Bipolar Adapter Cable, Model 72200022
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 28, 2009 as substantially equivalent to K061660 (Stryker Instruments, 2006) after a 61-day review. Its family tree reaches back 4 generations to 1999. 4 later devices descend from it.
- Decided
- Jan 28, 2009
- Review
- 61 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K991218 (1999). 14 ancestors in all, the oldest K896450 (1991). 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK991218 Oratec Bipolar Ablation ProbesOratec Interventions, Inc. · 1999
- 3 generations backK031371 Saphyre Bipolar Ablation ProbesSmith & Nephew, Inc. · 2003
- 2 generations backK043442 Stryker RF Coaxial Bipolar Electrodes & CannulaeStryker Instruments · 2005
- 1 generation backK061660 Stryker RF Parallel Bipolar Adaptor CableStryker Instruments · 2006
- This deviceK083528 Smith & Nephew Bipolar Adapter Cable, Model 72200022Smith & Nephew, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK111262 Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar…Olsen Medical · 2012 · Recalled
- Descendant · 2 generations on · 0 of its ownK241621 Da Vinci Monopolar and Bipolar Adapters (378896)Intuitive Surgical · 2024
- Descendant · 2 generations on · 0 of its ownK143662 Bissinger Monopolar Forceps and CablesMedagent, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK133167 Monopolar Cautery Cord, Bipolar Cautery CordIntuitive Surgical, Inc. · 2014
Most influential descendants
Showing 4 of 4 · See all- K111262Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar Cable/ Adapters…Olsen Medical · 2012 · cites it directly3descendants
- K241621Da Vinci Monopolar and Bipolar Adapters (378896)Intuitive Surgical · 2024 · 2 generations on0descendants
- K143662Bissinger Monopolar Forceps and CablesMedagent, Inc. · 2015 · 2 generations on0descendants
- K133167Monopolar Cautery Cord, Bipolar Cautery CordIntuitive Surgical, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K991218 | Oratec Bipolar Ablation Probes | Oratec Interventions, Inc. | 1999 | — |
| −3 | K031371 | Saphyre Bipolar Ablation Probes | Smith & Nephew, Inc. | 2003 | — |
| −2 | K043442 | Stryker RF Coaxial Bipolar Electrodes & Cannulae | Stryker Instruments | 2005 | — |
| −1 | K061660 | Stryker RF Parallel Bipolar Adaptor Cable | Stryker Instruments | 2006 | — |
| 0 (this device) | K083528 | Smith & Nephew Bipolar Adapter Cable, Model 72200022 | Smith & Nephew, Inc. | 2009 | — |
| +1 | K111262 | Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar Cable/… | Olsen Medical | 2012 | 2 |
| +2 | K241621 | Da Vinci Monopolar and Bipolar Adapters (378896) | Intuitive Surgical | 2024 | — |
| +2 | K143662 | Bissinger Monopolar Forceps and Cables | Medagent, Inc. | 2015 | — |
| +2 | K133167 | Monopolar Cautery Cord, Bipolar Cautery Cord | Intuitive Surgical, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2024 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K052878 | FDA’s K052878 is NT-1000 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2006 |
| * | K061660 | Stryker RF Parallel Bipolar Adaptor CableSummary page 1…on similarities in design features and overall indications for use: * Neurotherm NT 1000 RF Lesioning System - K52878 • Stryker RF Parallel Bipolar Adapter Cable - K061660 4 $F.KWCE~. DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2006 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111262 | Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar Cable/ Adapters… | 2012 | 3 |
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 10 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 14 ancestors have a recall of any class.
- Of its descendants, K111262 (Olsen Medical, 2012) has gone furthest, with 3 descendants 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. 2009, 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 Smith & Nephew Adaptor Cable is intended for connecting a Smith & Nephew Radiofrequency Denervation Probe to Smith & Nephew RF Lesion Generators.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083528 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083528: Smith & Nephew Bipolar Adapter Cable, Model 72200022.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083528
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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