510(k) · Cleared
ClearedElectrohydraulic Lithotriptor (TCS-B3-II)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · FFK Lithotriptor, Electro-Hydraulic
Cleared on Mar 21, 2025 as substantially equivalent to K230488 (Walz Elektronik GmbH, 2023) after a 179-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Mar 21, 2025
- Review
- 179 days
- Class
- Class II
- Product code
- FFK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K923822 (1993). 7 ancestors in all, the oldest K913955 (1991). No later device cites it as a predicate yet.
- Root · 3 generations backK923822 Autolith-IehlNorthgate Technologies, Inc. · 1993
- 2 generations backK130368 Autolith Touch; Uro TouchNorthgate Technologies, Inc. · 2013 · Recalled
- 1 generation backK230488 EL27-Compact; Sterile EHL-ProbesWalz Elektronik GmbH · 2023
- This deviceK242888 Electrohydraulic Lithotriptor (TCS-B3-II)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K923822 | Autolith-Iehl | Northgate Technologies, Inc. | 1993 | — |
| −2 | K130368 | Autolith Touch; Uro Touch | Northgate Technologies, Inc. | 2013 | 4 |
| −1 | K230488 | EL27-Compact; Sterile EHL-Probes | Walz Elektronik GmbH | 2023 | — |
| 0 (this device) | K242888 | Electrohydraulic Lithotriptor (TCS-B3-II) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 3 | 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 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? (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 |
|---|---|---|---|
| * | K230488 | EL27-Compact; Sterile EHL-ProbesSummary page 6…de Name: Electrohydraulic Lithotriptor (TCS-B3-II) Generic/Common Name: Lithotripter Model: TCS-B3-II III.Predicate Device Predicate Device 510(k) Number: K230488 Trade Name: EL27-Compact; Sterile EHL-Probes Regulation Name: Electrohydraulic lithotriptor Regulation Number:21 C… | 2023 |
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?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 9.8 years on median.
- 3 of the 7 ancestors have a recall of any class.
- 1 other device also cites its predicate K230488.
How does its category compare?
All FFK devicesFFK Lithotriptor, Electro-Hydraulic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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?
The Electrohydraulic Lithotriptor is intended to be used with Potent Medical disposable electrohydraulic lithotripsy (EHL) probes for disintegration of concernments in the bile duct.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242888 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242888: Electrohydraulic Lithotriptor (TCS-B3-II).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242888
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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