510(k) · Cleared
ClearedE-Z Clear Smoke Evacuation Electrosurgical Pencil;Clear Nozzle Extention, Ulpa Filter, Charcoal Filter, Adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Megadyne Medical Products, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Feb 18, 2015 as substantially equivalent to K961616 (I.C Medical, Inc., 1996) after a 250-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.
- Decided
- Feb 18, 2015
- Review
- 250 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961616 (1996). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK961616 Telescoping Penevac (Modification)I.C Medical, Inc. · 1996
- This deviceK141587 E-Z Clear Smoke Evacuation Electrosurgical Pencil;Clear Nozzle…Megadyne Medical Products, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK200253 Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne…Ethicon Endo-Surgery · 2020
- Descendant · cites it directly · 0 of its ownK170721 Cut-Vac Lighted Smoke Evacuation Electrosurgical PencilPrecision Surgical, LLC · 2017
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 |
|---|---|---|---|---|---|
| −1 | K961616 | Telescoping Penevac (Modification) | I.C Medical, Inc. | 1996 | — |
| 0 (this device) | K141587 | E-Z Clear Smoke Evacuation Electrosurgical Pencil;Clear Nozzle Extention, Ulpa… | Megadyne Medical Products, Inc. | 2015 | — |
| +1 | K200253 | Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne… | Ethicon Endo-Surgery | 2020 | — |
| +1 | K170721 | Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil | Precision Surgical, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K961616 | Telescoping Penevac (Modification)Summary page 4…ctrosurgical cutting and coagulation device and accessories (21 CFR 878.4400) Regulatory Class: . Class i Product Code: GEl lll. PREDICATE DEVICE Telescoping PenEvac, K961616 cleared May 28, 1996 IV. DEVICE DESCRIPTION The ZIP Pen Smoke Evacuation Electrosurgical Pencil is a sterile, single use hand h… | 1996 |
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?
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 ZIP Pen Smoke Evacuation Electrosurgical Pencil is a monopolar device 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 device conducts electrosurgical current from an electrosurgical generator and delivers it to the target tissue to achieve the desired surgical effect.
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/K141587 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141587: E-Z Clear Smoke Evacuation Electrosurgical Pencil;Clear Nozzle Extention, Ulpa Filter, Charcoal Filter, Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141587
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