510(k) · Cleared
ClearedPROPENCIL Smoke Pencil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio Protech, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 16, 2015 as substantially equivalent to K120454 (Lna Medical Aps, 2012) and 2 other predicates after a 260-day review. Its family tree reaches back 3 generations to 1979.
- Decided
- Jul 16, 2015
- Review
- 260 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K791137 (1979). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK791137 Single Use Monopolar Hand Control PencilDavol, Inc. · 1979 · Recalled
- 2 generations backK081634 Conmed Goldvac Integrated Smoke Evacuation PencilConmed Corporation · 2008
- 1 generation backK120454 Safeair Smoke Pencil,Lna Medical Aps · 2012
- This deviceK143103 PROPENCIL Smoke PencilBio Protech, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K791137 | Single Use Monopolar Hand Control Pencil | Davol, Inc. | 1979 | 12 |
| −2 | K081634 | Conmed Goldvac Integrated Smoke Evacuation Pencil | Conmed Corporation | 2008 | — |
| −1 | K120454 | Safeair Smoke Pencil, | Lna Medical Aps | 2012 | — |
| 0 (this device) | K143103 | PROPENCIL Smoke Pencil | Bio Protech, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2011 | 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? (3)
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 |
|---|---|---|---|
| * | K120454 | Safeair Smoke Pencil,Summary page 4…Electrosurgical, Cutting & Coagulation & Accessories Regulation Number: 878.4400 Product Code: GEI Device Class: Class II PREDICATE DEVICES: LiNA Medical SafeAir (K120454) Smoke pencil Conmed, Inc. ClearVac (K982309) smoke evacuation accessory with ESU Pencil (K791137)… | 2012 |
| * | K982309 | Smoke Evacuation Attachment 130XXX TBDSummary page 4…sories Regulation Number: 878.4400 Product Code: GEI Device Class: Class II PREDICATE DEVICES: LiNA Medical SafeAir (K120454) Smoke pencil Conmed, Inc. ClearVac (K982309) smoke evacuation accessory with ESU Pencil (K791137) Page 1 of 5… | 1998 |
| * | K791137 | Single Use Monopolar Hand Control PencilSummary page 4…I Device Class: Class II PREDICATE DEVICES: LiNA Medical SafeAir (K120454) Smoke pencil Conmed, Inc. ClearVac (K982309) smoke evacuation accessory with ESU Pencil (K791137) Page 1 of 5… | 1979 |
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 36 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 3 other devices also cite its predicate K120454.
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?
PROPENCIL™ Smoke pencil is designed for general electrosurgical applications and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143103: PROPENCIL Smoke Pencil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143103
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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