510(k) · Cleared
Recalled · Class II · 2022Autolith Touch; Uro Touch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Northgate Technologies, Inc. · FFK Lithotriptor, Electro-Hydraulic
Cleared on Nov 15, 2013 as substantially equivalent to K923822 (Northgate Technologies, Inc., 1993) after a 274-day review. Its family tree reaches back 1 generation to 1993. 4 later devices descend from it. It has been recalled 4 times.
- Decided
- Nov 15, 2013
- Review
- 274 days
- Class
- Class II
- Product code
- FFK
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923822 (1993). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK923822 Autolith-IehlNorthgate Technologies, Inc. · 1993
- This deviceK130368 Autolith Touch; Uro TouchNorthgate Technologies, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK230488 EL27-Compact; Sterile EHL-ProbesWalz Elektronik GmbH · 2023
- Descendant · 2 generations on · 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 · 2 generations on · 0 of its ownK242888 Electrohydraulic Lithotriptor (TCS-B3-II)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK202813 URO-TOUCH 9 French ProbeNorthgate Technologies, Inc. · 2021
Most influential descendants
Showing 4 of 4 · See all- K230488EL27-Compact; Sterile EHL-ProbesWalz Elektronik GmbH · 2023 · cites it directly2descendants
- K243032EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · 2025 · 2 generations on0descendants
- K242888Electrohydraulic Lithotriptor (TCS-B3-II)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · 2025 · 2 generations on0descendants
- K202813URO-TOUCH 9 French ProbeNorthgate Technologies, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923822 | Autolith-Iehl | Northgate Technologies, Inc. | 1993 | — |
| 0 (this device) | K130368 | Autolith Touch; Uro Touch | Northgate Technologies, Inc. | 2013 | — |
| +1 | K230488 | EL27-Compact; Sterile EHL-Probes | Walz Elektronik GmbH | 2023 | — |
| +2 | K243032 | EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025 | — |
| +2 | K242888 | Electrohydraulic Lithotriptor (TCS-B3-II) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025 | — |
| +1 | K202813 | URO-TOUCH 9 French Probe | Northgate Technologies, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K923822 | Autolith-IehlSummary page 2…-weight design. The predicate device is: AutolitO For Renal and Biliary Procedures, (K(923822), approved, January 28, 1993. Device Description: The AUTOLITH® TOUCH unit is designed to be used with N… | 1993 |
What descends from it? (4)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 13, 2022 | Class II | Z-1235-2022 | Under Investigation by firm | Product labeled incorrectly. |
| Oct 25, 2021 | Class II | Z-0333-2022 | Software design (manufacturing process) | The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device. |
| Mar 10, 2020 | Class II | Z-1883-2020 | Nonconforming Material/Component | As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. |
| Mar 10, 2020 | Class II | Z-1884-2020 | Nonconforming Material/Component | Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K230488 (Walz Elektronik GmbH, 2023) has gone furthest, with 2 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. 2013, 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 AUTOLITH® TOUCH unit is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of biliary calculi. The AUTOLITH® URO-TOUCH unit is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of renal calculi.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130368 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130368: Autolith Touch; Uro Touch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130368
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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