510(k) · Cleared
ClearedC-Trak Biopsy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Care Wise Medical Products Corp. · IZD Probe, Uptake, Nuclear
Cleared on Oct 14, 1992 after a 162-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Oct 14, 1992
- Review
- 162 days
- Class
- Class I
- Product code
- IZD
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK922117 C-Trak Biopsy SystemCare Wise Medical Products Corp. · 1992
- Descendant · cites it directly · 3 of its ownK971167 Neoprobe Model 1500 Portable Radioisotope Detector and AccessoriesNeoprobe Corp. · 1997
- Descendant · 2 generations on · 1 of its ownK013751 Handheld Gamma Finder (HGF)Silicon Instruments Gmhb · 2002
- Descendant · 2 generations on · 0 of its ownK101887 Confident Surgery Suite 300, Model CSS300Surgiceye GmbH · 2011
- Descendant · cites it directly · 0 of its ownK982442 C-Trak Automatic Analyzer (Name Change From Oncoprobe II to C-Trak)Care Wise Medical Products Corp. · 1998
Most influential descendants
Showing 4 of 4 · See all- K971167Neoprobe Model 1500 Portable Radioisotope Detector and AccessoriesNeoprobe Corp. · 1997 · cites it directly3descendants
- K013751Handheld Gamma Finder (HGF)Silicon Instruments Gmhb · 2002 · 2 generations on1descendant
- K101887Confident Surgery Suite 300, Model CSS300Surgiceye GmbH · 2011 · 2 generations on0descendants
- K982442C-Trak Automatic Analyzer (Name Change From Oncoprobe II to C-Trak)Care Wise Medical Products Corp. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K922117 | C-Trak Biopsy System | Care Wise Medical Products Corp. | 1992 | — |
| +1 | K971167 | Neoprobe Model 1500 Portable Radioisotope Detector and Accessories | Neoprobe Corp. | 1997 | — |
| +2 | K013751 | Handheld Gamma Finder (HGF) | Silicon Instruments Gmhb | 2002 | — |
| +2 | K101887 | Confident Surgery Suite 300, Model CSS300 | Surgiceye GmbH | 2011 | — |
| +1 | K982442 | C-Trak Automatic Analyzer (Name Change From Oncoprobe II to C-Trak) | Care Wise Medical Products Corp. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IZD? 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K971167 (Neoprobe Corp., 1997) has gone furthest, with 3 descendants of its own.
How does its category compare?
All IZD devicesIZD Probe, Uptake, Nuclear: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZD
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · IZD
Too few IZD 510(k)s in any year since 2007 to give a median.
Recalls per year · IZD
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZD
8in 2025
MAUDE reports naming product code IZD, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 2 | 4 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K922117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K922117: C-Trak Biopsy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922117
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026