510(k) · Cleared
ClearedNeptune E-SEP Smoke Evacuation Pencil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 13, 2016 as substantially equivalent to K153679 (Stryker Corporation, 2016) after a 30-day review. Its family tree reaches back 6 generations to 1979. 2 later devices descend from it.
- Decided
- Apr 13, 2016
- Review
- 30 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K791137 (1979). 12 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK791137 Single Use Monopolar Hand Control PencilDavol, Inc. · 1979 · Recalled
- 5 generations backK081634 Conmed Goldvac Integrated Smoke Evacuation PencilConmed Corporation · 2008
- 4 generations backK120454 Safeair Smoke Pencil,Lna Medical Aps · 2012
- 3 generations backK142538 LiNA SafeAir Smoke PencilLina Medical Aps · 2014
- 2 generations backK143145 SafeAir Smoke PencilLina Medical Aps · 2014 · Recalled
- 1 generation backK153679 Stryker Neptune E-SEP Smoke Evacuation PencilStryker Corporation · 2016
- This deviceK160693 Neptune E-SEP Smoke Evacuation PencilStryker Corporation · 2016
- Descendant · cites it directly · 0 of its ownK261959 Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm…Stryker Instruments · 2026
- Descendant · cites it directly · 0 of its ownK182354 SafeAir Telescopic Smoke PencilLina Medical Aps · 2018 · Recalled
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 |
|---|---|---|---|---|---|
| −6 | K791137 | Single Use Monopolar Hand Control Pencil | Davol, Inc. | 1979 | 12 |
| −5 | K081634 | Conmed Goldvac Integrated Smoke Evacuation Pencil | Conmed Corporation | 2008 | — |
| −4 | K120454 | Safeair Smoke Pencil, | Lna Medical Aps | 2012 | — |
| −3 | K142538 | LiNA SafeAir Smoke Pencil | Lina Medical Aps | 2014 | — |
| −2 | K143145 | SafeAir Smoke Pencil | Lina Medical Aps | 2014 | 8 |
| −1 | K153679 | Stryker Neptune E-SEP Smoke Evacuation Pencil | Stryker Corporation | 2016 | — |
| 0 (this device) | K160693 | Neptune E-SEP Smoke Evacuation Pencil | Stryker Corporation | 2016 | — |
| +1 | K261959 | Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade… | Stryker Instruments | 2026 | — |
| +1 | K182354 | SafeAir Telescopic Smoke Pencil | Lina Medical Aps | 2018 | 4 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K153679 | Stryker Neptune E-SEP Smoke Evacuation PencilSummary page 5…Product Code Trade Name Manufacturer Stryker® Neptune® E-SEP™ K153679 GEI Stryker… | 2016 |
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?
- The line of descent spans 37 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K261959 (Stryker Instruments, 2026) 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. 2016, 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 Neptune E-SEP is an Integrated Smoke Evacuation Pencil (pencil) 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 an electrosurgical current from the output connector of an electrosurgical unit (generator) to the operative site for the desired surgical effect.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160693 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160693: Neptune E-SEP Smoke Evacuation Pencil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160693
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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