510(k) · Cleared
ClearedAem Disposable Suction Irrigation Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encision, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 26, 2013 as substantially equivalent to K100711 (Encision, Inc., 2010) and 1 other predicate after a 60-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Aug 26, 2013
- Review
- 60 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K934094 (1994). 10 ancestors in all, the oldest K912780 (1991). No later device cites it as a predicate yet.
- Root · 3 generations backK934094 Stryker Laparoscopic Suction IrrigatorStryker Corp. · 1994 · Recalled
- 2 generations backK963765 Stryker Strykeflow Electrocautery ProbesStryker Endoscopy · 1997 · Recalled
- 1 generation backK100711 Suction Irrigation Electrodes and AdaptersEncision, Inc. · 2010 · Recalled
- This deviceK131949 Aem Disposable Suction Irrigation ElectrodesEncision, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K934094 | Stryker Laparoscopic Suction Irrigator | Stryker Corp. | 1994 | 3 |
| −2 | K963765 | Stryker Strykeflow Electrocautery Probes | Stryker Endoscopy | 1997 | 1 |
| −1 | K100711 | Suction Irrigation Electrodes and Adapters | Encision, Inc. | 2010 | 5 |
| 0 (this device) | K131949 | Aem Disposable Suction Irrigation Electrodes | Encision, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K100711 | Suction Irrigation Electrodes and AdaptersSummary page 1…astic Surgery Primary Trade Name AEM Suction Irrigation Electrode Predicate Manufacturer Encision Inc Cleared by 510(k): K100711 Secondary Trade Name AEM Disposable Suction Irrigation Electrode and Predicate Handset… | 2010 |
| * | K122580 | Aem Disposable Suction Irrigation Handset Model ES1700; Aem Disposable Suction…Summary page 1…sable Suction Irrigation Electrode and Predicate Handset Manufacturer Encision Inc Cleared by 510(k): K122580 Device Description General AEM Single-Use Suction Irrigation Instruments are description *Electrosurgical acce… | 2012 |
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 19 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 7 of the 10 ancestors have a recall of any class.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site. These accessories have applications in general endoscopy and laparoscopy procedures.
AEM instruments incorporate the use of AEM technology and are intended for use with the AEM monitoring system and electrosurgical generators compatible with the AEM system
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131949 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131949: Aem Disposable Suction Irrigation Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131949
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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