510(k) · Cleared
ClearedARC 400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bowa-Electronics GmbH & Co. KG · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 2, 2020 as substantially equivalent to K171717 (KARL STORZ Endoscopy-America, Inc., 2017) after a 101-day review. Its family tree reaches back 4 generations to 1994. 1 later device descends from it.
- Decided
- Apr 2, 2020
- Review
- 101 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K933002 (1994). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK933002 Erbotom Icc 350Erbe USA, Inc. · 1994
- 3 generations backK023886 Erbe Vio Esu with Accessories, Model Vio 300 DErbe USA, Inc. · 2002
- 2 generations backK060484 Erbe Vio Esu, Model Vio 300 DErbe USA, Inc. · 2006
- 1 generation backK171717 Autocon Iii 400KARL STORZ Endoscopy-America, Inc. · 2017
- This deviceK193591 ARC 400Bowa-Electronics GmbH & Co. KG · 2020
- Descendant · cites it directly · 0 of its ownK230194 HF Surgery Generator 400KHZRichard Wolf Medical Instruments Corporation · 2023
Most influential descendants
Showing 1 of 1 · See all- K230194HF Surgery Generator 400KHZRichard Wolf Medical Instruments Corporation · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933002 | Erbotom Icc 350 | Erbe USA, Inc. | 1994 | — |
| −3 | K023886 | Erbe Vio Esu with Accessories, Model Vio 300 D | Erbe USA, Inc. | 2002 | — |
| −2 | K060484 | Erbe Vio Esu, Model Vio 300 D | Erbe USA, Inc. | 2006 | — |
| −1 | K171717 | Autocon Iii 400 | KARL STORZ Endoscopy-America, Inc. | 2017 | — |
| 0 (this device) | K193591 | ARC 400 | Bowa-Electronics GmbH & Co. KG | 2020 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K171717 | Autocon Iii 400Summary page 4…lassification Panel: General & Plastic Surgery 5. Legally Marketed Predicate Device(s) Device name: AUTOCON III 400 510(k) number: K171717 Manufacturer: KARL STORZ SE & Co. KG Page 1 of 4 === Page 5 ==… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230194 | HF Surgery Generator 400KHZ | 2023 | 0 |
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 26 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K230194 (Richard Wolf Medical Instruments Corporation, 2023) has gone furthest, with 0 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. 2020, 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 High Frequency (HF) device is intended exclusively for the generation of electrical power for monopolar and bipolar cutting and coagulation of tissue structures in surgical operations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193591 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193591: ARC 400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193591
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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