Neoprobe Corp.: FDA clearances and approvals
Neoprobe Corp. has 6 FDA 510(k) clearances (first 1986, latest 2005), across 2 product codes in 2 review panels. Median 510(k) review time: 88 days. openFDA lists 2 product recalls by a recalling firm named Neoprobe Corp.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IZD | Probe, Uptake, Nuclear | 5 | 5 |
| DPW | Flowmeter, Blood, Cardiovascular | 1 | 1 |
Review panels
- Radiology (5)
- Cardiovascular (1)
Most recent Neoprobe Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050088 | QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER | DPW | 2005-02-08 | 26 |
| K971167 | NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES | IZD | 1997-06-26 | 87 |
| K962319 | NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES | IZD | 1996-09-13 | 88 |
| K942580 | NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES | IZD | 1995-02-09 | 254 |
| K915279 | NEOPROBE PORTABLE RADIOSCOPE DETECTOR | IZD | 1992-06-10 | 198 |
| K864263 | NEOPROBE PORTABLE RADIOISOTOPE DETECTOR | IZD | 1986-12-29 | 61 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2004-12-13.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Neoprobe Corp. have?
Neoprobe Corp. has 6 FDA 510(k) clearances (first 1986, latest 2005), across 2 product codes in 2 review panels.
How long does FDA take to clear Neoprobe Corp.'s 510(k)s?
The median time from FDA receipt to decision across Neoprobe Corp.'s cleared 510(k)s is 88 days.
What devices does Neoprobe Corp. make?
Its most frequent FDA product codes are IZD (Probe, Uptake, Nuclear, 5); DPW (Flowmeter, Blood, Cardiovascular, 1).
Has Neoprobe Corp. had device recalls?
openFDA lists 2 product recalls in 1 recall event by a recalling firm whose name matches Neoprobe Corp; the most recent began 2004-12-13. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 6 Neoprobe Corp. clearances with predicates and recalls
- Run predicate analysis for product code IZD, Neoprobe Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.