510(k) Report

510(k) · Cleared

Cleared

Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)

K261959510(k) SpecialCleared Sep 17, 202698-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stryker Instruments · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Sep 17, 2026 as substantially equivalent to K160693 (Stryker Corporation, 2016) after a 98-day review. Its family tree reaches back 7 generations to 1979.

Decided
Sep 17, 2026
Review
98 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
1

Its longest line of descent runs back 7 generations to K791137 (1979). 13 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 1 other ancestor1996: 1 other ancestor2000: 1 other ancestor1998: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestorK791137 · Single Use Monopolar Hand Control Pencil · Davol, Inc. · 1979 · recalledK081634 · Conmed Goldvac Integrated Smoke Evacuation Pencil · Conmed Corporation · 2008K120454 · Safeair Smoke Pencil, · Lna Medical Aps · 2012×2: 2 generations cleared close together, K142538 (2014), K143145 (2014) ×2: 2 generations cleared close together, K153679 (2016), K160693 (2016) 19801990200020102020
Other ancestors, by generation 5 generations back: 2 other ancestors6 generations back: 4 other ancestors K160693 · Neptune E-SEP Smoke Evacuation Pencil · Stryker Corporation · 2016K153679 · Stryker Neptune E-SEP Smoke Evacuation Pencil · Stryker Corporation · 2016K143145 · SafeAir Smoke Pencil · Lina Medical Aps · 2014 · recalledK142538 · LiNA SafeAir Smoke Pencil · Lina Medical Aps · 2014K120454 · Safeair Smoke Pencil, · Lna Medical Aps · 2012K081634 · Conmed Goldvac Integrated Smoke Evacuation Pencil · Conmed Corporation · 2008K791137 · Single Use Monopolar Hand Control Pencil · Davol, Inc. · 1979 · recalled−50
  1. Root · 7 generations backK791137 Single Use Monopolar Hand Control PencilDavol, Inc. · 1979 · Recalled
  2. 6 generations backK081634 Conmed Goldvac Integrated Smoke Evacuation PencilConmed Corporation · 2008
  3. 5 generations backK120454 Safeair Smoke Pencil,Lna Medical Aps · 2012
  4. 4 generations backK142538 LiNA SafeAir Smoke PencilLina Medical Aps · 2014
  5. 3 generations backK143145 SafeAir Smoke PencilLina Medical Aps · 2014 · Recalled
  6. 2 generations backK153679 Stryker Neptune E-SEP Smoke Evacuation PencilStryker Corporation · 2016
  7. 1 generation backK160693 Neptune E-SEP Smoke Evacuation PencilStryker Corporation · 2016
  8. This deviceK261959 Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm…Stryker Instruments · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K791137Single Use Monopolar Hand Control PencilDavol, Inc.197912
−6K081634Conmed Goldvac Integrated Smoke Evacuation PencilConmed Corporation2008—
−5K120454Safeair Smoke Pencil,Lna Medical Aps2012—
−4K142538LiNA SafeAir Smoke PencilLina Medical Aps2014—
−3K143145SafeAir Smoke PencilLina Medical Aps20148
−2K153679Stryker Neptune E-SEP Smoke Evacuation PencilStryker Corporation2016—
−1K160693Neptune E-SEP Smoke Evacuation PencilStryker Corporation2016—
0 (this device)K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade…Stryker Instruments2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199510
199610
199810
200010
201110
FIG. 1 — Lineage of K261959, 1979–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K160693Neptune E-SEP Smoke Evacuation Pencil
Summary page 4
…rrent from the output connector of an electrosurgical unit (generator) to the operative site for the desired surgical effect. The indications for use are unchanged from K160693. Please select the types of uses (select one or both, as Prescription Use (21 CFR 801 Subpart D) applicable). [ ] Over-The-Count…
Stryker Corporation2016—

Also cleared against K160693: 1 other device →

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 47 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
  • 3 of the 13 ancestors have a recall of any class.
  • 1 other device also cites its predicate K160693.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

The Neptune SafeAir Pencils are 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K160693

1 other device cites the same predicate.

  • K182354SafeAir Telescopic Smoke PencilLina Medical Aps · 20184 recalls

More from Stryker Instruments

77 FDA decisions under this applicant name. See the company

  • K262386SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch…Stryker Instruments · 2026
  • K262244Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000); Sonopet iQ+…Stryker Instruments · 2026
  • K261544Hydro Irrigation SystemStryker Instruments · 2026
  • K253679Hydro Irrigation SystemStryker Instruments · 2026
  • K252282SurgiCount+ SystemStryker Instruments · 2026

Recent decisions in GEI

The GEI category page

  • K262386SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch…Stryker Instruments · 2026
  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
  • K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC · 2026
  • K254185Potenza PrimeJeisys Medical Incorporated · 2026
  • K262364Ellian Enigma RF DeviceEllian Corp · 2026

https://510kreport.com/device/K261959 · printed Nov 6, 2026

Cite this page

510(k) Report. “K261959: Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261959

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026