510(k) · Cleared
ClearedAutocon Iii 400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 2, 2017 as substantially equivalent to K062464 (KARL STORZ Endoscopy-America, Inc., 2007) and 1 other predicate after a 54-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it.
- Decided
- Aug 2, 2017
- Review
- 54 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K933002 (1994). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
- 2 generations backK023886 Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc. · 2002
- 1 generation backK060484 Erbe Vio Esu, Model Vio 300 DErbe USA, Inc. · 2006
- This deviceK171717 Autocon Iii 400KARL STORZ Endoscopy-America, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK193591 ARC 400Bowa-Electronics GmbH & Co. KG · 2020
- Descendant · 2 generations on · 0 of its ownK230194 HF Surgery Generator 400KHZRichard Wolf Medical Instruments Corporation · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933002 | Erbotom Icc 350 | Erbe USA, Inc. | 1994 | — |
| −2 | K023886 | Erbe Vio Esu with Accessories, Model Vio 300 D | Erbe USA, Inc. | 2002 | — |
| −1 | K060484 | Erbe Vio Esu, Model Vio 300 D | Erbe USA, Inc. | 2006 | — |
| 0 (this device) | K171717 | Autocon Iii 400 | KARL STORZ Endoscopy-America, Inc. | 2017 | — |
| +1 | K193591 | ARC 400 | Bowa-Electronics GmbH & Co. KG | 2020 | — |
| +2 | K230194 | HF Surgery Generator 400KHZ | Richard Wolf Medical Instruments Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K062464 | Modification to Autocon II 400 Electrosurgical GeneratorSummary page 4…CFR part 878.4400 (Electrosurgical cutting and coagulation device and accessories) Predicate Primary Predicate Device: AUTOCON II 400 (K062464) Device(s): /N Second Predicate Device: ERBE VIO 300D (K060484) These predicate… | 2007 |
| * | K060484 | Erbe Vio Esu, Model Vio 300 DSummary page 4…accessories) Predicate Primary Predicate Device: AUTOCON II 400 (K062464) Device(s): /N Second Predicate Device: ERBE VIO 300D (K060484) These predicate devices have not been subject to a design-related recall. Device The AUTOC… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193591 | ARC 400 | 2020 | 1 |
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 23 years and passes through 2 companies; a new generation was cleared every 8.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K193591 (Bowa-Electronics GmbH & Co. KG, 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K062464.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 AUTOCON III 400 is intended for use by qualified surgeons to provide a high frequency electrical current for monopolar and bipolar cutting and coagulation of tissue structures during surgical operations.
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/K171717 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171717: Autocon Iii 400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171717
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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