510(k) · Cleared
Recalled · 2004Suction Pump for Intracorporeal Ultrasound Lithotripter and Accessories, Model 2207.XXX
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 Sep 17, 2001 as substantially equivalent to K011065 (Richard Wolf Medical Instruments Corp., 2001) after a 90-day review. Its family tree reaches back 1 generation to 2001. It has been recalled once.
- Decided
- Sep 17, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- FFK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011065 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK011065 Intracorporeal Ultrasound Lithotripter, Model 2271.004, Ultrasound…Richard Wolf Medical Instruments Corp. · 2001 · Recalled
- This deviceK011911 Suction Pump for Intracorporeal Ultrasound Lithotripter and…Richard Wolf Medical Instruments Corp. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011065 | Intracorporeal Ultrasound Lithotripter, Model 2271.004, Ultrasound Transducer… | Richard Wolf Medical Instruments Corp. | 2001 | 1 |
| 0 (this device) | K011911 | Suction Pump for Intracorporeal Ultrasound Lithotripter and Accessories, Model… | Richard Wolf Medical Instruments Corp. | 2001 | — |
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? (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 |
|---|---|---|---|
| * | K011065 | Intracorporeal Ultrasound Lithotripter, Model 2271.004, Ultrasound Transducer, Model… | 2001 |
| * | — | Suction pump 2017.00 Named without a submission 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 |
|---|---|---|---|---|
| Feb 2, 2004 | Not classified | Z-0537-04 | Other | If the drain tube is assembled incorrectly, the suction pump will not operate as intended. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a 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?
Suction pump 2207 with its accessories is used to aspirate liquids in ultrasound lithotripsy. It has been designed for combined use with the ultrasound generator 2271. In conjunction with ultrasound generator 2271 the suction pump is exclusively used for aspiration of disintegrated kidney stones, bladder stones and ureter stones and the liquid involved. Contraindications: Contraindications directly related to the product are presently unknown. On the…
Read the full statement (156 words)
Suction pump 2207 with its accessories is used to aspirate liquids in ultrasound lithotripsy. It has been designed for combined use with the ultrasound generator 2271. In conjunction with ultrasound generator 2271 the suction pump is exclusively used for aspiration of disintegrated kidney stones, bladder stones and ureter stones and the liquid involved.
Contraindications: Contraindications directly related to the product are presently unknown. On the basis of the patient's general condition the doctor in charge must decide whether the planned use is possible or not. For further information see the latest medical literature.
Combinations: The R.Wolf “Suction Pump 2207” is specially designed for use with an ultrasound lithotriptor. It is specially designed for combined use with the WOLF US-LITHO 2271.
If the suction pump is to be used in conjunction with other ultrasound lithotriptors (other marks, brands), the user must check whether the device combination can reach and maintain the required functions on a continuous basis.
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/K011911 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011911: Suction Pump for Intracorporeal Ultrasound Lithotripter and Accessories, Model 2207.XXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011911
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026