510(k) · Cleared
ClearedShinEvac Smoke Evacuation Pencil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shining World Health Care Co., Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 28, 2022 as substantially equivalent to K103375 (Medtek Devices, Inc., 2011) after a 116-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Jan 28, 2022
- Review
- 116 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K936304 (1994). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK936304 Electrosurgical PencilE & M Engineering, Inc. · 1994 · Recalled
- 1 generation backK103375 Plumepen Integrated Smoke Evacuation PencilMedtek Devices, Inc. · 2011
- This deviceK213317 ShinEvac Smoke Evacuation PencilShining World Health Care Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK250400 Vigeon Laparoscopic Universal Smoke Evacuator (VG003)Vigeon Technology Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K250400Vigeon Laparoscopic Universal Smoke Evacuator (VG003)Vigeon Technology Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K936304 | Electrosurgical Pencil | E & M Engineering, Inc. | 1994 | 3 |
| −1 | K103375 | Plumepen Integrated Smoke Evacuation Pencil | Medtek Devices, Inc. | 2011 | — |
| 0 (this device) | K213317 | ShinEvac Smoke Evacuation Pencil | Shining World Health Care Co., Ltd. | 2022 | — |
| +1 | K250400 | Vigeon Laparoscopic Universal Smoke Evacuator (VG003) | Vigeon Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K103375 | Plumepen Integrated Smoke Evacuation PencilSummary page 5…I Product Code: GEI 3 Predicate Device Name PLUMEPEN® Integrated Smoke Evacuation Pencil 510(k) number K103375 Trade/Device Name: PLUMEPEN Regulation Number: 21 CFR 878.4400… | 2011 |
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 |
|---|---|---|---|
| K250400 | Vigeon Laparoscopic Universal Smoke Evacuator (VG003) | 2025 | 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 28 years and passes through 3 companies; a new generation was cleared every 16.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K250400 (Vigeon Technology Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K103375.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 ShinEvac@ Smoke Evacuation Pencil is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct and electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213317 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213317: ShinEvac Smoke Evacuation Pencil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213317
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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