510(k) · Cleared
ClearedAURORA Evacuator +Coag
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rebound Therapeutics · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Dec 2, 2021 as substantially equivalent to K960455 (Kirwan Surgical Products, Inc., 1996) and 1 other predicate after a 345-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Dec 2, 2021
- Review
- 345 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K960455 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK960455 Bipolar Suction CoagulatorKirwan Surgical Products, Inc. · 1996
- 1 generation backK201637 Aurora Evacuator +CoagRebound Therapeutics · 2020
- This deviceK203745 AURORA Evacuator +CoagRebound Therapeutics · 2021
- Descendant · cites it directly · 0 of its ownK230125 Neuroblade SystemClearmind Biomedical · 2023
Most influential descendants
Showing 1 of 1 · See all- K230125Neuroblade SystemClearmind Biomedical · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960455 | Bipolar Suction Coagulator | Kirwan Surgical Products, Inc. | 1996 | — |
| −1 | K201637 | Aurora Evacuator +Coag | Rebound Therapeutics | 2020 | — |
| 0 (this device) | K203745 | AURORA Evacuator +Coag | Rebound Therapeutics | 2021 | — |
| +1 | K230125 | Neuroblade System | Clearmind Biomedical | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K960455 | Bipolar Suction CoagulatorSummary page 4…FR 878.4400 Regulation Name: Electrosurgical Cutting & Coagulation Device & Accessories Regulatory Class: II Product Code: GEI PREDICATE DEVICE K960455, Bipolar Suction Coagulator, Kirwan Surgical Products (primary predicate) K201637, AURORA Evacuator +Coag, Rebound Therapeutics (… | 1996 |
| * | K201637 | Aurora Evacuator +CoagSummary page 4…& Accessories Regulatory Class: II Product Code: GEI PREDICATE DEVICE K960455, Bipolar Suction Coagulator, Kirwan Surgical Products (primary predicate) K201637, AURORA Evacuator +Coag, Rebound Therapeutics (secondary predicate) K190075/K180372, AURORA Evacuator, Rebound Therapeutics (refe… | 2020 |
| † | K190075 | Aurora Evacuator | 2019 |
| † | K180372 | Aurora Evacuator | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230125 | Neuroblade System | 2023 | 0 |
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 25 years and passes through 2 companies; a new generation was cleared every 24.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K230125 (Clearmind Biomedical, 2023) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K960455.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 AURORA Evacuator +Coag is a powered instrument with a handpiece intended for removal of soft tissue and fluids, and coagulation of tissue under direct visualization. Types of direct visualization may include laparoscopic, pelviscopic, endoscopic, percutaneous, and open. Applications include those when access to the surgical site is limited, such as neurosurgical.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203745 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203745: AURORA Evacuator +Coag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203745
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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