510(k) · Cleared
Recalled · 2004Aeh-3 Electrohydraulic Lithotripter and Probes (E-1F, E-3F, E-5F, and E-9F)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Circon Acmi · FFK Lithotriptor, Electro-Hydraulic
Cleared on Nov 17, 1998 after a 281-day review. The FDA summary names no predicate by number. It has been recalled 4 times.
- Decided
- Nov 17, 1998
- Review
- 281 days
- Class
- Class II
- Product code
- FFK
- Recalls
- 4
- Predicates
- 0
The FDA summary names no predicate by number.
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 FFK? 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 FFK device
- #1 K230488 EL27-Compact; Sterile EHL-Probesscore 12.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 30, 2004 | Not classified | Z-0928-04 | Other | Product sterility may be compromised due to the lack of package seal integrity |
| Apr 30, 2004 | Not classified | Z-0925-04 | Other | Product sterility may be compromised due to the lack of package seal integrity |
| Apr 30, 2004 | Not classified | Z-0926-04 | Other | Product sterility may be compromised due to the lack of package seal integrity |
| Apr 30, 2004 | Not classified | Z-0927-04 | Other | Product sterility may be compromised due to the lack of package seal integrity |
No ancestor or descendant has a Class I recall.
How does its category compare?
All FFK devicesFFK Lithotriptor, Electro-Hydraulic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FFK
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FFK
110in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FFK
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FFK
6in 2025
MAUDE reports naming product code FFK, 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 | 2 | — | 1 | 6 |
| 2008 | 0 | — | 0 | 12 |
| 2009 | 0 | — | 1 | 35 |
| 2010 | 2 | — | 0 | 16 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 3 | 110 | 0 | 10 |
| 2014 | 0 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 2 | — | 0 | 7 |
| 2017 | 0 | — | 1 | 9 |
| 2018 | 0 | — | 0 | 18 |
| 2019 | 1 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 39 |
| 2021 | 1 | — | 1 | 22 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 1 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 2 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
CIRCON ACMTI’s AEH-3 Electrohydraulic Lithotripter and Probes are intended to be used to fragment stones (calculi) in the urinary and biliary tracts, including the kidney, ureter, bladder, urethra, and common bile duct.
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/K980492 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980492: Aeh-3 Electrohydraulic Lithotripter and Probes (E-1F, E-3F, E-5F, and E-9F).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980492
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026