510(k) · Cleared
ClearedErbe APCapplicators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Erbe Elektromedizin GmbH · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 4, 2019 as substantially equivalent to K003462 (Erbe USA, Inc., 2001) after a 113-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Apr 4, 2019
- Review
- 113 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003462 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK003462 Erbe Apc Handle and Applicators, Model…Erbe USA, Inc. · 2001
- This deviceK183445 Erbe APCapplicatorsErbe Elektromedizin GmbH · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003462 | Erbe Apc Handle and Applicators, Model… | Erbe USA, Inc. | 2001 | — |
| 0 (this device) | K183445 | Erbe APCapplicators | Erbe Elektromedizin GmbH | 2019 | — |
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 |
|---|---|---|---|
| * | K003462 | Erbe Apc Handle and Applicators, Model…Summary page 4…Regulatory Class: II Product Code: GEI Legally Marketed Predicate Device: ERBE APC Handle and Applicators – K003462 Device Description: The Erbe APCapplicators are sterile, single-use electrosurgical instruments for monopolar cutting and coagul… | 2001 |
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?
- Its one ancestor has no recall.
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?
Product Number (P/N) 20132-250, 20132-251, 20132-252, 20132-253, 20132-254 and 20132-255: The Rigid Argon Plasma Coagulation Applicators are intended for monopolar cutting and coagulation of tissue with and without argon gas or for coagulation and ablation using argon plasma. They are used in open and in laparoscopic surgery.
P/N 20132-256: The Rigid Argon Plasma Coagulation Applicator is intended for monopolar coagulation and ablation of tissue using argon plasma. It is used in open surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183445 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183445: Erbe APCapplicators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183445
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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