Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neoprobe Corp. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
254 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050088 | QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL | Neoprobe Corp. | 2005-02-08 | 26 | 0 |
| K971167 | NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCES | Neoprobe Corp. | 1997-06-26 | 87 | 0 |
| K962319 | NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESS | Neoprobe Corp. | 1996-09-13 | 88 | 0 |
| K942580 | NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES | Neoprobe Corp. | 1995-02-09 | 254 | 0 |
| K915279 | NEOPROBE PORTABLE RADIOSCOPE DETECTOR | Neoprobe Corp. | 1992-06-10 | 198 | 0 |
| K864263 | NEOPROBE PORTABLE RADIOISOTOPE DETECTOR | Neoprobe Corp. | 1986-12-29 | 61 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda