510(k) · Cleared
ClearedEL27-Compact; Sterile EHL-Probes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Walz Elektronik GmbH · FFK Lithotriptor, Electro-Hydraulic
Cleared on Aug 31, 2023 as substantially equivalent to K130368 (Northgate Technologies, Inc., 2013) and 4 other predicates after a 189-day review. Its family tree reaches back 2 generations to 1993. 2 later devices descend from it.
- Decided
- Aug 31, 2023
- Review
- 189 days
- Class
- Class II
- Product code
- FFK
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K923822 (1993). 6 ancestors in all, the oldest K913955 (1991). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK923822 Autolith-IehlNorthgate Technologies, Inc. · 1993
- 1 generation backK130368 Autolith Touch; Uro TouchNorthgate Technologies, Inc. · 2013 · Recalled
- This deviceK230488 EL27-Compact; Sterile EHL-ProbesWalz Elektronik GmbH · 2023
- Descendant · cites it directly · 0 of its ownK243032 EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK242888 Electrohydraulic Lithotriptor (TCS-B3-II)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See all- K243032EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · 2025 · cites it directly0descendants
- K242888Electrohydraulic Lithotriptor (TCS-B3-II)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923822 | Autolith-Iehl | Northgate Technologies, Inc. | 1993 | — |
| −1 | K130368 | Autolith Touch; Uro Touch | Northgate Technologies, Inc. | 2013 | 4 |
| 0 (this device) | K230488 | EL27-Compact; Sterile EHL-Probes | Walz Elektronik GmbH | 2023 | — |
| +1 | K243032 | EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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 K243032 EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL…score 9.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K130368 | Autolith Touch; Uro TouchSummary page 4…Predicate Device 510(k) No. AUTOLITH TOUCH K130368 AUTOLITH URO-TOUCH K130368 1.9 FRENCH LITHOTRIPTER ELECTRODE… | 2013 |
| * | K914514 | 1.9 French Lithotripter Electrode, ModificationSummary page 4…O-TOUCH K130368 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION K914514 3 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION K914515 9 FRENCH LITHOTRIPTER ELECTRODE,… | 1992 |
| * | K914515 | 3 French Lithotripter Electrode, ModificationSummary page 4…LITHOTRIPTER ELECTRODE, MODIFICATION K914514 3 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION K914515 9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION K914516 1.9 FRENCH LITHOTRIPTER ELECTRODE… | 1992 |
| * | K914516 | 9 French Lithotripter Electrode, ModificationSummary page 4…THOTRIPTER ELECTRODE, MODIFICATION K914515 9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION K914516 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION K913955 @Elektronik GmbH… | 1992 |
| * | K913955 | 1.9 French Lithotripter Electrode, ModificationSummary page 4…THOTRIPTER ELECTRODE, MODIFICATION K914516 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION K913955 @Elektronik GmbH 05-510k Summary.docx… | 1991 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 30 years and passes through 2 companies; a new generation was cleared every 20.8 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K243032 (Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K130368.
How does its category compare?
All FFK devicesFFK Lithotriptor, Electro-Hydraulic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 EL27-Compact is a device to be used together with EHL-probes from Walz Elektronik GmbH for disintegration of concernments in the upper and lower urinary tract and in gastroenterology, particularly in the bile duct.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230488 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230488: EL27-Compact; Sterile EHL-Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230488
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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