510(k) · Cleared
Recalled · 2003Intracorporeal Ultrasound Lithotripter, Model 2271.004, Ultrasound Transducer, Model 2271.501, Ultrasound Probes (Sono)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · FFK Lithotriptor, Electro-Hydraulic
Cleared on May 9, 2001 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled once.
- Decided
- May 9, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- FFK
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK011065 Intracorporeal Ultrasound Lithotripter, Model 2271.004, Ultrasound…Richard Wolf Medical Instruments Corp. · 2001
- Descendant · cites it directly · 0 of its ownK011911 Suction Pump for Intracorporeal Ultrasound Lithotripter and…Richard Wolf Medical Instruments Corp. · 2001 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K011911Suction Pump for Intracorporeal Ultrasound Lithotripter and Accessories, Model 2207.XXXRichard Wolf Medical Instruments Corp. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011065 | Intracorporeal Ultrasound Lithotripter, Model 2271.004, Ultrasound Transducer… | Richard Wolf Medical Instruments Corp. | 2001 | — |
| +1 | K011911 | Suction Pump for Intracorporeal Ultrasound Lithotripter and Accessories, Model… | Richard Wolf Medical Instruments Corp. | 2001 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|
| K011911 | Suction Pump for Intracorporeal Ultrasound Lithotripter and Accessories, Model 2207.XXX | 2001 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 9, 2003 | Not classified | Z-0081-04 | Other | The sonotrode tube could become blocked by the stone fragments, causing overheating and damage to the device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K011911 (Richard Wolf Medical Instruments Corp., 2001) has gone furthest, with 0 descendants of its own.
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 | — |
https://510kreport.com/device/K011065 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011065: Intracorporeal Ultrasound Lithotripter, Model 2271.004, Ultrasound Transducer, Model 2271.501, Ultrasound Probes (Sono).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011065
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026