510(k) · Cleared
ClearedNeoprobe 1000 Portable Radioisotope Detector and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neoprobe Corp. · IZD Probe, Uptake, Nuclear
Cleared on Feb 9, 1995 after a 254-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Feb 9, 1995
- Review
- 254 days
- Class
- Class I
- Product code
- IZD
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK942580 Neoprobe 1000 Portable Radioisotope Detector and AccessoriesNeoprobe Corp. · 1995
- Descendant · cites it directly · 4 of its ownK962319 Neoprobe 1000 Gen 1C Portable Radioisotope Detector & AccessoriesNeoprobe Corp. · 1996
- Descendant · 2 generations on · 3 of its ownK971167 Neoprobe Model 1500 Portable Radioisotope Detector and AccessoriesNeoprobe Corp. · 1997
- Descendant · 3 generations on · 1 of its ownK013751 Handheld Gamma Finder (HGF)Silicon Instruments Gmhb · 2002
- Descendant · 3 generations on · 0 of its ownK101887 Confident Surgery Suite 300, Model CSS300Surgiceye GmbH · 2011
- Descendant · 3 generations on · 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 5 of 5 · See all- K962319Neoprobe 1000 Gen 1C Portable Radioisotope Detector & AccessoriesNeoprobe Corp. · 1996 · cites it directly4descendants
- K971167Neoprobe Model 1500 Portable Radioisotope Detector and AccessoriesNeoprobe Corp. · 1997 · 2 generations on3descendants
- K013751Handheld Gamma Finder (HGF)Silicon Instruments Gmhb · 2002 · 3 generations on1descendant
- K101887Confident Surgery Suite 300, Model CSS300Surgiceye GmbH · 2011 · 3 generations on0descendants
- K982442C-Trak Automatic Analyzer (Name Change From Oncoprobe II to C-Trak)Care Wise Medical Products Corp. · 1998 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942580 | Neoprobe 1000 Portable Radioisotope Detector and Accessories | Neoprobe Corp. | 1995 | — |
| +1 | K962319 | Neoprobe 1000 Gen 1C Portable Radioisotope Detector & Accessories | Neoprobe Corp. | 1996 | — |
| +2 | K971167 | Neoprobe Model 1500 Portable Radioisotope Detector and Accessories | Neoprobe Corp. | 1997 | — |
| +3 | K013751 | Handheld Gamma Finder (HGF) | Silicon Instruments Gmhb | 2002 | — |
| +3 | K101887 | Confident Surgery Suite 300, Model CSS300 | Surgiceye GmbH | 2011 | — |
| +3 | 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 |
|---|---|---|
| 1996 | 1 | 0 |
| 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K962319 | Neoprobe 1000 Gen 1C Portable Radioisotope Detector & Accessories | 1996 | 4 |
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, K962319 (Neoprobe Corp., 1996) has gone furthest, with 4 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/K942580 · printed Nov 6, 2026
Cite this page
510(k) Report. “K942580: Neoprobe 1000 Portable Radioisotope Detector and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942580
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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