510(k) · Cleared
ClearedAed Monopolar Lap Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
National Advanced Endoscopy Devices, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 25, 2008 as substantially equivalent to K052759 (Dannoritzer Medizintechnik GmbH & Co. KG, 2006) and 1 other predicate after a 119-day review. Its family tree reaches back 4 generations to 1994. 7 later devices descend from it.
- Decided
- Sep 25, 2008
- Review
- 119 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K932832 (1994). 18 ancestors in all, the oldest K913281 (1991). 7 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK932832 Primus Insulated ForcepsMarlo Surgical Technology · 1994
- 3 generations backK021237 Coopersurgical Laparoscopic InstrumentsCooperSurgical, Inc. · 2003
- 2 generations backK043013 Miltex Laparoscopic InstrumentsMiltex, Inc. · 2005
- 1 generation backK052759 Dan Monopolar Lap AccessoriesDannoritzer Medizintechnik GmbH & Co. KG · 2006 · Recalled
- This deviceK081503 Aed Monopolar Lap AccessoriesNational Advanced Endoscopy Devices, Inc. · 2008
- Descendant · cites it directly · 6 of its ownK103508 Unmiax Laparoscopic InstrumentUnimax Medical Systems, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK142208 Monopolar Laparascopic AccessoriesUnimicro Medical Systems (Shenzhen) Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK230621 LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic ProbesSurgical Principals, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK230650 Monopolar Electrode Surgical InstrumentVhmed (Nantong) Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK192235 AEON Laparoscopic InstrumentsLexington Medical, Inc. · 2019
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K103508Unmiax Laparoscopic InstrumentUnimax Medical Systems, Inc. · 2011 · cites it directly6descendants
- K142208Monopolar Laparascopic AccessoriesUnimicro Medical Systems (Shenzhen) Co., Ltd. · 2015 · 2 generations on1descendant
- K230621LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic ProbesSurgical Principals, Inc. · 2023 · 2 generations on0descendants
- K230650Monopolar Electrode Surgical InstrumentVhmed (Nantong) Co., Ltd. · 2023 · 3 generations on0descendants
- K192235AEON Laparoscopic InstrumentsLexington Medical, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K932832 | Primus Insulated Forceps | Marlo Surgical Technology | 1994 | — |
| −3 | K021237 | Coopersurgical Laparoscopic Instruments | CooperSurgical, Inc. | 2003 | — |
| −2 | K043013 | Miltex Laparoscopic Instruments | Miltex, Inc. | 2005 | — |
| −1 | K052759 | Dan Monopolar Lap Accessories | Dannoritzer Medizintechnik GmbH & Co. KG | 2006 | 1 |
| 0 (this device) | K081503 | Aed Monopolar Lap Accessories | National Advanced Endoscopy Devices, Inc. | 2008 | — |
| +1 | K103508 | Unmiax Laparoscopic Instrument | Unimax Medical Systems, Inc. | 2011 | — |
| +2 | K142208 | Monopolar Laparascopic Accessories | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 2015 | — |
| +2 | K230621 | LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes | Surgical Principals, Inc. | 2023 | — |
| +3 | K230650 | Monopolar Electrode Surgical Instrument | Vhmed (Nantong) Co., Ltd. | 2023 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K052759 | Dan Monopolar Lap AccessoriesSummary page 1…(GEl, 21 CFR 878.4400) Predicate Devices: Dan Monopolar Lap Accessories, Dannoritzer Medizintechnik GmbH, K052759 Gyrus Open Forceps, Gyrus Medical, Inc., K024286 Device Description: A… | 2006 |
| * | K024286 | Gyrus Open ForcepsSummary page 1…essories, Dannoritzer Medizintechnik GmbH, K052759 Gyrus Open Forceps, Gyrus Medical, Inc., K024286 Device Description: AED Monopolar Lap Accessories consist of = Standar… | 2003 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103508 | Unmiax Laparoscopic Instrument | 2011 | 6 |
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 14 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 5 of the 18 ancestors have a recall of any class.
- Of its descendants, K103508 (Unimax Medical Systems, Inc., 2011) has gone furthest, with 6 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. 2008, 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?
AED Monopolar Lap Accessories are reusable devices'(forceps and electrodes) intended to be used in general laparoscopic surgical procedures requiring the use of electrosurgical cutting and/or coagulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081503 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081503: Aed Monopolar Lap Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081503
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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