510(k) · Cleared
ClearedCautery Tip Cleaner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Key Surgical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 22, 2015 as substantially equivalent to K053433 (Xodus Medical, Inc., 2006) after a 15-day review. Its family tree reaches back 2 generations to 2003. 1 later device descends from it.
- Decided
- May 22, 2015
- Review
- 15 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K030339 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK030339 Cautery Tip Cleaner, Model-TC-100Aspen Surgical Products, Inc. · 2003
- 1 generation backK053433 Cautery Tip Cleaner, Model 30500Xodus Medical, Inc. · 2006 · Recalled
- This deviceK151222 Cautery Tip CleanerKey Surgical, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK241022 Sterile single use tip cleaner (WK800-S10 , WK800-S20)Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · 2024
Most influential descendants
Showing 1 of 1 · See all- K241022Sterile single use tip cleaner (WK800-S10 , WK800-S20)Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K030339 | Cautery Tip Cleaner, Model-TC-100 | Aspen Surgical Products, Inc. | 2003 | — |
| −1 | K053433 | Cautery Tip Cleaner, Model 30500 | Xodus Medical, Inc. | 2006 | 3 |
| 0 (this device) | K151222 | Cautery Tip Cleaner | Key Surgical, Inc. | 2015 | — |
| +1 | K241022 | Sterile single use tip cleaner (WK800-S10 , WK800-S20) | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K053433 | Cautery Tip Cleaner, Model 30500Summary page 4…GEl Performance Standards: No Recognized Consensus Standards Predicate Device: Cautery Tip Cleaner, cleared on 01/19/2006 via K053433 Trade Name: None… | 2006 |
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 |
|---|---|---|---|
| K241022 | Sterile single use tip cleaner (WK800-S10 , WK800-S20) | 2024 | 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 12 years and passes through 3 companies; a new generation was cleared every 9.3 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K241022 (Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd, 2024) 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. 2015, 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 disposable cautery tip cleaner is a single use sterile device intended to be used as an electrosurgical accessory to remove eschar buildup from the tips of electrosurgical cauterization blades during surgical procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151222 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151222: Cautery Tip Cleaner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151222
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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