510(k) · Cleared
ClearedPatton Tripol
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Patton Medical Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 30, 2002 as substantially equivalent to K993055 (United States Surgical, A Division of Tyco Healthc, 1999) and 1 other predicate after a 285-day review. Its family tree reaches back 2 generations to 1994. 4 later devices descend from it.
- Decided
- Apr 30, 2002
- Review
- 285 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K945975 (1994). 3 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK945975 Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) ForcepsEverest Medical Corp. · 1994
- 1 generation backK971565 Bicoag Coagulating ForcepsEverest Medical Corp. · 1998
- This deviceK012279 Patton TripolPatton Medical Corp. · 2002
- Descendant · cites it directly · 3 of its ownK023813 Bipolar ForcepsRichard Wolf Medical Instruments Corp. · 2003
- Descendant · 2 generations on · 1 of its ownK113597 Mini-Lap Bipolar Electrocautery DevicesMinilap Technologies · 2012
- Descendant · 3 generations on · 0 of its ownK172775 MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip…Teleflexmedical, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK081553 Aed Bipolar Forceps, Model 13-1646National Advanced Endoscopy Devices, Inc. · 2008
Most influential descendants
Showing 4 of 4 · See all- K023813Bipolar ForcepsRichard Wolf Medical Instruments Corp. · 2003 · cites it directly3descendants
- K113597Mini-Lap Bipolar Electrocautery DevicesMinilap Technologies · 2012 · 2 generations on1descendant
- K172775MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip HandleTeleflexmedical, Inc. · 2018 · 3 generations on0descendants
- K081553Aed Bipolar Forceps, Model 13-1646National Advanced Endoscopy Devices, Inc. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945975 | Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps | Everest Medical Corp. | 1994 | — |
| −1 | K971565 | Bicoag Coagulating Forceps | Everest Medical Corp. | 1998 | — |
| 0 (this device) | K012279 | Patton Tripol | Patton Medical Corp. | 2002 | — |
| +1 | K023813 | Bipolar Forceps | Richard Wolf Medical Instruments Corp. | 2003 | — |
| +2 | K113597 | Mini-Lap Bipolar Electrocautery Devices | Minilap Technologies | 2012 | — |
| +3 | K172775 | MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle | Teleflexmedical, Inc. | 2018 | — |
| +2 | K081553 | Aed Bipolar Forceps, Model 13-1646 | National Advanced Endoscopy Devices, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K993055 | Dexide Bipolar Forceps II** DeviceSummary page 1…mmon Name: Bipolar Forceps ey 5 3 Classification: DEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES i~ Predicate Devices: DEXIDE BIPOLAR FORCEPS II** DEVICE (K993055), manufactured fiy . United States Surgical, 150 Glover Avenue, Norwalk, CT 06856. BICOAG COAGULATING FORCEPS (K971565) manufactu… | 1999 |
| * | K971565 | Bicoag Coagulating ForcepsSummary page 1…icate Devices: DEXIDE BIPOLAR FORCEPS II** DEVICE (K993055), manufactured fiy . United States Surgical, 150 Glover Avenue, Norwalk, CT 06856. BICOAG COAGULATING FORCEPS (K971565) manufactured by Everest Medical Corp., 13756 First Avenue, North, Suite 500, Minneapolis, MN 55441. Description of Device: The… | 1998 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023813 | Bipolar Forceps | 2003 | 3 |
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 8 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K023813 (Richard Wolf Medical Instruments Corp., 2003) has gone furthest, with 3 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.
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 Patton Tripol is intended for use in open and laparoscopic surgeries where grasping, coagulating, and transecting of tissue is indicated.
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/K012279 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012279: Patton Tripol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012279
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026