510(k) · Cleared
ClearedAEON Laparoscopic Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lexington Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 11, 2019 as substantially equivalent to K103508 (Unimax Medical Systems, Inc., 2011) after a 53-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Oct 11, 2019
- Review
- 53 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K932832 (1994). 20 ancestors in all, the oldest K913281 (1991). No later device cites it as a predicate yet.
- Root · 6 generations backK932832 Primus Insulated ForcepsMarlo Surgical Technology · 1994
- 5 generations backK021237 Coopersurgical Laparoscopic InstrumentsCooperSurgical, Inc. · 2003
- 4 generations backK043013 Miltex Laparoscopic InstrumentsMiltex, Inc. · 2005
- 3 generations backK052759 Dan Monopolar Lap AccessoriesDannoritzer Medizintechnik GmbH & Co. KG · 2006 · Recalled
- 2 generations backK081503 Aed Monopolar Lap AccessoriesNational Advanced Endoscopy Devices, Inc. · 2008
- 1 generation backK103508 Unmiax Laparoscopic InstrumentUnimax Medical Systems, Inc. · 2011
- This deviceK192235 AEON Laparoscopic InstrumentsLexington Medical, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K932832 | Primus Insulated Forceps | Marlo Surgical Technology | 1994 | — |
| −5 | K021237 | Coopersurgical Laparoscopic Instruments | CooperSurgical, Inc. | 2003 | — |
| −4 | K043013 | Miltex Laparoscopic Instruments | Miltex, Inc. | 2005 | — |
| −3 | K052759 | Dan Monopolar Lap Accessories | Dannoritzer Medizintechnik GmbH & Co. KG | 2006 | 1 |
| −2 | K081503 | Aed Monopolar Lap Accessories | National Advanced Endoscopy Devices, Inc. | 2008 | — |
| −1 | K103508 | Unmiax Laparoscopic Instrument | Unimax Medical Systems, Inc. | 2011 | — |
| 0 (this device) | K192235 | AEON Laparoscopic Instruments | Lexington Medical, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K103508 | Unmiax Laparoscopic InstrumentSummary page 4…21 CFR 878.4440 Device Class: II Classification Panel: General & Plastic Surgery Product Code: GEI 5. Predicate Device Identification 510(k) Number: K103508 Product Name: Unimax Laparoscopic Instrument Manufacturer: Unimax Medical Systems Inc. 6. Device Description The… | 2011 |
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 7 companies; a new generation was cleared every 3.2 years on median.
- 5 of the 20 ancestors have a recall of any class.
- 4 other devices also cite its predicate K103508.
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?
AEON™ Laparoscopic Instruments is a family of instruments which includes forceps, scissors, and probes which are intended to be used in general laparoscopic surgical procedures requiring the use of monopolar electrosurgical cutting and/or coagulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192235 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192235: AEON Laparoscopic Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192235
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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