510(k) · Cleared
ClearedNeoprobe 1000 Gen 1C Portable Radioisotope Detector & 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 Sep 13, 1996 as substantially equivalent to K942580 (Neoprobe Corp., 1995) after an 88-day review. Its family tree reaches back 1 generation to 1995. 4 later devices descend from it.
- Decided
- Sep 13, 1996
- Review
- 88 days
- Class
- Class I
- Product code
- IZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K942580 (1995). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK942580 Neoprobe 1000 Portable Radioisotope Detector and AccessoriesNeoprobe Corp. · 1995
- This deviceK962319 Neoprobe 1000 Gen 1C Portable Radioisotope Detector & AccessoriesNeoprobe Corp. · 1996
- 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 · 2 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 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 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942580 | Neoprobe 1000 Portable Radioisotope Detector and Accessories | Neoprobe Corp. | 1995 | — |
| 0 (this device) | 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 | — |
| +2 | K013751 | Handheld Gamma Finder (HGF) | Silicon Instruments Gmhb | 2002 | — |
| +2 | K101887 | Confident Surgery Suite 300, Model CSS300 | Surgiceye GmbH | 2011 | — |
| +2 | 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), 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? (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 |
|---|---|---|---|
| * | K942580 | Neoprobe 1000 Portable Radioisotope Detector and AccessoriesSummary page 2…r and accessories Classification Name Nuclear uptake probe and accessories Predicate Device Neoprobe Model 1000 GEN 1B Portable Radioisotope Detector and Accessories (K942580) Intended Use The NeoprobeO Model 1000 GEN 1C Portable Radioisotope Detector is an electronic device intended to detect and qua… | 1995 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K971167 | Neoprobe Model 1500 Portable Radioisotope Detector and Accessories | 1997 | 3 |
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?
- Its one ancestor has no recall.
- 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 | — |
What is it indicated for?
The Neoprobe® Model 1000 GEN 1C Portable Radioisotope Detector is an electronic device intended to detect and quantify gamma radiation. The GEN 1C is indicated for external and intraoperative detection of radioactivity in body tissues or organs in medical procedures where gamma emitting isotopes 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/K962319 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962319: Neoprobe 1000 Gen 1C Portable Radioisotope Detector & Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962319
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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