510(k) · Cleared
ClearedObs Disposable Electrosurgical Pencils, Models: Obs-DB, Obs-DR, Obs-DF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangmen City Xinhui Baisheng Medical Equipment CO · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Dec 1, 2009 as substantially equivalent to K033027 (Shining World Health Care Co., Ltd., 2004) and 2 other predicates after a 96-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Dec 1, 2009
- Review
- 96 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K001270 (2000). 7 ancestors in all, the oldest K993647 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK001270 Gyrus Endourology System: Axipolar Resectoscope Loop ElectrodeGyrus Medical, Ltd. · 2000
- 2 generations backK031085 Gyrus Plasmakinetic Superpulse System (Generator, Accessories)Gyrus Medical, Inc. · 2003
- 1 generation backK033027 Shinmed Various Models of Electro-Surgical Pencils, SW12200…Shining World Health Care Co., Ltd. · 2004
- This deviceK092634 Obs Disposable Electrosurgical Pencils, Models: Obs-DB, Obs-DR, Obs-DFJiangmen City Xinhui Baisheng Medical Equipment CO · 2009
- Descendant · cites it directly · 0 of its ownK170369 Disposable Electrosurgical PencilsCathay Manfacturing Corp. · 2018
Most influential descendants
Showing 1 of 1 · See all- K170369Disposable Electrosurgical PencilsCathay Manfacturing Corp. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001270 | Gyrus Endourology System: Axipolar Resectoscope Loop Electrode | Gyrus Medical, Ltd. | 2000 | — |
| −2 | K031085 | Gyrus Plasmakinetic Superpulse System (Generator, Accessories) | Gyrus Medical, Inc. | 2003 | — |
| −1 | K033027 | Shinmed Various Models of Electro-Surgical Pencils, SW12200, SW12202, SW12300 | Shining World Health Care Co., Ltd. | 2004 | — |
| 0 (this device) | K092634 | Obs Disposable Electrosurgical Pencils, Models: Obs-DB, Obs-DR, Obs-DF | Jiangmen City Xinhui Baisheng Medical Equipment CO | 2009 | — |
| +1 | K170369 | Disposable Electrosurgical Pencils | Cathay Manfacturing Corp. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K033027 | Shinmed Various Models of Electro-Surgical Pencils, SW12200, SW12202, SW12300Summary page 1…China(Taiwan) Proprietary Name: SHINMVED various models of electra-surgical p3encils model SWi12200,SW1 2202, SW1 2300 It's 510(K) number is K033027 Code: FDA-005 Version: A/0 IPage 1 of 3 Issuing Date: 10.2009 O~~~~~… | 2004 |
| * | K993647 | Unimed Disposable Hand and Foot-Switching Pencils with Holster and 1BLADE and Tip…Summary page 2…oduc ts, Inc. Address: 10401 Belcher Road Largo, Florida 33777 Proprietary Name: Disposable Hand and Foot-Switching Pencil It's 510O(K) number is K993647 3) Tecno Instruments(PVT) Ltd Company Name: Tecno Instruments(PVT) Ltd Address: 316-C Small Industrial Est… | 1999 |
| * | K002257 | Tecno Disposable Fingerswitch Pencil, Model 150-100Summary page 2…316-C Small Industrial Estate Sialkot-5i1340 Pakistan Proprietary Name: Tecno Disposable Fingerswitch Pencil Model: 150-100 It's 510(K) number is K002257 4.0 Device Description The OBS Disposable Electrosurgical Pencils, models: OBS-Db, OBS-Dr, OBS-Df are used for… | 2000 |
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 |
|---|---|---|---|
| K170369 | Disposable Electrosurgical Pencils | 2018 | 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 9 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K170369 (Cathay Manfacturing Corp., 2018) 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. 2009, 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 025 Disposable Electrosurgical Pencils, models: OBS-Db, OBS-Dr, OBS-Df are used for cutting and coagulation to remove tissue and control bleeding by using high frequency current during electrosurgical surgery with a 510Ok-clearance ESU generator. The device is disposable and supplied sterile with an electrode tip.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092634 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092634: Obs Disposable Electrosurgical Pencils, Models: Obs-DB, Obs-DR, Obs-DF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092634
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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