510(k) · Cleared
ClearedCAS-One Liver
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cascination AG · OEW Tracking, Soft Tissue, Intraoperative
Cleared on Apr 28, 2015 as substantially equivalent to K101979 (Pathfinder Therapeutics, Inc., 2011) after a 189-day review. Its family tree reaches back 4 generations to 1988.
- Decided
- Apr 28, 2015
- Review
- 189 days
- Class
- Class II
- Product code
- OEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K882383 (1988). 18 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK882383 Maggi Series Ultra. Needle, Biopsy/Catheter GuidesCIVCO Medical Instruments Co., Inc. · 1988
- 3 generations backK974432 Ultraguide 1000Ultraguide, Ltd. · 1998
- 2 generations backK083728 Invision SystemInneroptic Technology, Inc. · 2009
- 1 generation backK101979 Explorer Liver (Passive Tracking)Pathfinder Therapeutics, Inc. · 2011
- This deviceK143024 CAS-One LiverCascination AG · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K882383 | Maggi Series Ultra. Needle, Biopsy/Catheter Guides | CIVCO Medical Instruments Co., Inc. | 1988 | — |
| −3 | K974432 | Ultraguide 1000 | Ultraguide, Ltd. | 1998 | — |
| −2 | K083728 | Invision System | Inneroptic Technology, Inc. | 2009 | — |
| −1 | K101979 | Explorer Liver (Passive Tracking) | Pathfinder Therapeutics, Inc. | 2011 | — |
| 0 (this device) | K143024 | CAS-One Liver | Cascination AG | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 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 OEW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K101979 | Explorer Liver (Passive Tracking)Summary page 5…ar or the same as the selected predicate device. The following predicate device was selected: Pathfinder Therapeutics, Inc. EXPLORER Liver - Passive Tracking [K101979] The predicate device was shown to have the same indications for use and intended use. A comparison of the following key technol… | 2011 |
| † | K132108 | MAXIO | 2014 |
| † | K082060 | Cranial Image Guided Surgery System | 2009 |
| † | K083310 | Spine & Trauma Ict | 2009 |
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 27 years and passes through 5 companies; a new generation was cleared every 9.2 years on median.
- 3 of the 18 ancestors have a recall of any class.
How does its category compare?
All OEW devicesOEW Tracking, Soft Tissue, Intraoperative: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OEW
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · OEW
Too few OEW 510(k)s in any year since 2007 to give a median.
Recalls per year · OEW
No recall names OEW since 2007.
Adverse event reports per year · OEW
1in 2012
MAUDE reports naming product code OEW, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CAS-One Liver system is indicated for open liver surgical procedures where image guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143024 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143024: CAS-One Liver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143024
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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