510(k) · Cleared
ClearedEasyInstruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agency For Medical Innovations GmbH · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 11, 2019 as substantially equivalent to K962119 (Microline Pentax, Inc., 1996) and 2 other predicates after a 227-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Mar 11, 2019
- Review
- 227 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K935270 (1994). 10 ancestors in all, the oldest K932648 (1993). No later device cites it as a predicate yet.
- Root · 4 generations backK935270 Modular Forcep and Scissor SystemRichard Wolf Medical Instruments Corp. · 1994
- 3 generations backK033249 Pajunk Modular Handle InstrumentsPajunk GmbH · 2004
- 2 generations backK102921 Endoscopic Monopolar Instruments and AccessoriesBema-GmbH & Co. KG · 2011
- 1 generation backK163615 Snowden-Pencer MicroLap 3mm Laparoscopic InstrumentsCarefusion 2200, Inc. · 2017
- This deviceK182013 EasyInstrumentsAgency For Medical Innovations GmbH · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K935270 | Modular Forcep and Scissor System | Richard Wolf Medical Instruments Corp. | 1994 | — |
| −3 | K033249 | Pajunk Modular Handle Instruments | Pajunk GmbH | 2004 | — |
| −2 | K102921 | Endoscopic Monopolar Instruments and Accessories | Bema-GmbH & Co. KG | 2011 | — |
| −1 | K163615 | Snowden-Pencer MicroLap 3mm Laparoscopic Instruments | Carefusion 2200, Inc. | 2017 | — |
| 0 (this device) | K182013 | EasyInstruments | Agency For Medical Innovations GmbH | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 2 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K962119 | RE-New Laparoscopic InstrumentsSummary page 5…icate Device Name / Manufacturer Primary Reference Number Predicate Predicate K962119 ReNew Laparoscopic Instruments / Microline K160706 ReNew V Handpiece Laparoscopic Instruments /… | 1996 |
| * | K160706 | ReNew V Handpiece Laparoscopic InstrumentsSummary page 5…Number Predicate Predicate K962119 ReNew Laparoscopic Instruments / Microline K160706 ReNew V Handpiece Laparoscopic Instruments / Microline K163615 Snowden-Pencer Microlap 3mm Laparoscopic… | 2016 |
| * | K163615 | Snowden-Pencer MicroLap 3mm Laparoscopic InstrumentsSummary page 5…Predicate K962119 ReNew Laparoscopic Instruments / Microline K160706 ReNew V Handpiece Laparoscopic Instruments / Microline K163615 Snowden-Pencer Microlap 3mm Laparoscopic Instruments / CareFusion 2200 Inc. K933002 Erbotom ICC 350 / E… | 2017 |
| † | K933002 | Erbotom Icc 350 | 1994 |
| † | K023886 | Erbe Vio Esu with Accessories, Model Vio 300 D | 2002 |
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 25 years and passes through 5 companies; a new generation was cleared every 7.8 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 10 other devices also cite its predicate K962119.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Easylnstruments are indicated for cutting, grasping, dissecting and coagulation of tissue in laparoscopic surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182013 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182013: EasyInstruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182013
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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