510(k) · Cleared
ClearedAura 70 Watt Bipolar Electrosurgical Coagulators, Models 28-2000 and 28-2600
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kirwan Surgical Products, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 20, 2005 after a 69-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Oct 20, 2005
- Review
- 69 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK052203 Aura 70 Watt Bipolar Electrosurgical Coagulators, Models 28-2000 and…Kirwan Surgical Products, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK231872 Polaris Bipolar Electrosurgical Generator (29-1000); Polaris…Kirwan Surgical Products, LLC · 2023
- Descendant · cites it directly · 0 of its ownK061544 Stellartech 100 Coagulation SystemStellartech Research Corp. · 2006
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) | K052203 | Aura 70 Watt Bipolar Electrosurgical Coagulators, Models 28-2000 and 28-2600 | Kirwan Surgical Products, Inc. | 2005 | — |
| +1 | K231872 | Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module… | Kirwan Surgical Products, LLC | 2023 | — |
| +1 | K061544 | Stellartech 100 Coagulation System | Stellartech Research Corp. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2023 | 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? (4)
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 |
|---|---|---|---|
| * | — | 28-1000, Kirwan 50 Watt Bipolar Generator Named without a submission number | |
| * | — | 26-2500, Aura, 20 Watt Bipolar Electrosurgical Coagulator Named without a submission number | |
| * | — | RF111, Pegasys Electrosurgical Generator Named without a submission number | |
| * | — | 80-1170, Malis TM Bipolar Electrosurgical System CMC-Ill Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K231872 (Kirwan Surgical Products, LLC, 2023) has gone furthest, with 0 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.
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?
General purpose solid state bipolar generator to supply RF signal to electrosurgical hand-pieces used on soft body tissue where a wide range of tissue types, patient conditions and load impedances are encountered. Where applicable (i.e., Auraplus, 28-2600) a peristaltic irrigation pump controls flow rate individually or simultaneously while coagulating.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052203: Aura 70 Watt Bipolar Electrosurgical Coagulators, Models 28-2000 and 28-2600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052203
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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