510(k) · Cleared
ClearedC-Trak Automatic Analyzer (Name Change From Oncoprobe II to C-Trak)
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 Aug 25, 1998 as substantially equivalent to K971167 (Neoprobe Corp., 1997) and 2 other predicates after a 42-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Aug 25, 1998
- Review
- 42 days
- Class
- Class I
- Product code
- IZD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K942580 (1995). 5 ancestors in all, the oldest K896588 (1990). No later device cites it as a predicate yet.
- Root · 3 generations backK942580 Neoprobe 1000 Portable Radioisotope Detector and AccessoriesNeoprobe Corp. · 1995
- 2 generations backK962319 Neoprobe 1000 Gen 1C Portable Radioisotope Detector & AccessoriesNeoprobe Corp. · 1996
- 1 generation backK971167 Neoprobe Model 1500 Portable Radioisotope Detector and AccessoriesNeoprobe Corp. · 1997
- This deviceK982442 C-Trak Automatic Analyzer (Name Change From Oncoprobe II to C-Trak)Care Wise Medical Products Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K942580 | Neoprobe 1000 Portable Radioisotope Detector and Accessories | Neoprobe Corp. | 1995 | — |
| −2 | K962319 | Neoprobe 1000 Gen 1C Portable Radioisotope Detector & Accessories | Neoprobe Corp. | 1996 | — |
| −1 | K971167 | Neoprobe Model 1500 Portable Radioisotope Detector and Accessories | Neoprobe Corp. | 1997 | — |
| 0 (this device) | K982442 | C-Trak Automatic Analyzer (Name Change From Oncoprobe II to C-Trak) | Care Wise Medical Products Corp. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 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 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? (3)
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 |
|---|---|---|---|
| * | K971167 | Neoprobe Model 1500 Portable Radioisotope Detector and AccessoriesSummary page 2…= Page 2 === T-29-1888 9:52AM e T NV Predicate Devices NeoProbe 1000 and 1500 Analyzers and accessories currently marketed by the NeoProbe Corporation of Dublin, Ohio (K971167) Care Wise C-Trak® Biopsy System (K922117) Care Wise OncoProbe 1I™ Analyzer (K896588) Intended Use The intended use of the de… | 1997 |
| * | K922117 | C-Trak Biopsy SystemSummary page 2…cate Devices NeoProbe 1000 and 1500 Analyzers and accessories currently marketed by the NeoProbe Corporation of Dublin, Ohio (K971167) Care Wise C-Trak® Biopsy System (K922117) Care Wise OncoProbe 1I™ Analyzer (K896588) Intended Use The intended use of the device here in question, i.e. the Care Wise C… | 1992 |
| * | K896588 | Oncoprobe II SystemSummary page 2…rs and accessories currently marketed by the NeoProbe Corporation of Dublin, Ohio (K971167) Care Wise C-Trak® Biopsy System (K922117) Care Wise OncoProbe 1I™ Analyzer (K896588) Intended Use The intended use of the device here in question, i.e. the Care Wise C-Trak® Automatic Analyzer, remains unchanged… | 1990 |
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 3 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K971167.
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 | — |
What is it indicated for?
The intended use of the device here in question, i.e. the Care Wise C-Trak Automatic Analyzer, remains unchanged from the intended use of prior predicate Care Wise and other portable radioisotope detectors. The Care Wise C-Trak Automatic Analyzer is designed-as are all similar devices- to detect and quantify the nuclear radiation. It is indicated for external and intraoperative detection of radioactivity in body tissues or organs, such as bowel, bone, lymphatics, and red blood cells, where radiopharmaceuticals are administered.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982442 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982442: C-Trak Automatic Analyzer (Name Change From Oncoprobe II to C-Trak).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982442
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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