510(k) · Cleared
ClearedSterile single use tip cleaner (WK800-S10 , WK800-S20)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 11, 2024 as substantially equivalent to K151222 (Key Surgical, Inc., 2015) after an 87-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- Jul 11, 2024
- Review
- 87 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K030339 (2003). No later device cites it as a predicate yet.
- Root · 3 generations backK030339 Cautery Tip Cleaner, Model-TC-100Aspen Surgical Products, Inc. · 2003
- 2 generations backK053433 Cautery Tip Cleaner, Model 30500Xodus Medical, Inc. · 2006 · Recalled
- 1 generation backK151222 Cautery Tip CleanerKey Surgical, Inc. · 2015
- This deviceK241022 Sterile single use tip cleaner (WK800-S10 , WK800-S20)Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K030339 | Cautery Tip Cleaner, Model-TC-100 | Aspen Surgical Products, Inc. | 2003 | — |
| −2 | K053433 | Cautery Tip Cleaner, Model 30500 | Xodus Medical, Inc. | 2006 | 3 |
| −1 | K151222 | Cautery Tip Cleaner | Key Surgical, Inc. | 2015 | — |
| 0 (this device) | K241022 | Sterile single use tip cleaner (WK800-S10 , WK800-S20) | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2024 | — |
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 |
|---|---|---|---|
| * | K151222 | Cautery Tip CleanerSummary page 5…ation & Accessories) 3. Predicative Device Manufacturer: Key Surgical Incorporated Trade/Device Name: Key Surgical® Cautery Tip Cleaner Product Code: GEI 510(k) Number: K151222 4. Indication for Use The sterile single use tip cleaner is a single use sterile device intended to be used as an electrosurgic… | 2015 |
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?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 9.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 sterile single use 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 as stated in the FDA summary.
https://510kreport.com/device/K241022 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241022: Sterile single use tip cleaner (WK800-S10 , WK800-S20).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241022
Report an extraction error
Are you the manufacturer?
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