Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nicolet Biomedical, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
218 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K021986 | BRAINET | Nicolet Biomedical, Inc. | 2002-08-23 | 66 | 0 |
| K021144 | SUBDURAL STRIP ELECTRODE | Nicolet Biomedical, Inc. | 2002-06-24 | 76 | 0 |
| K020218 | SNAP EEG MONITOR | Nicolet Biomedical, Inc. | 2002-04-22 | 90 | 0 |
| K020955 | NICOLET ELECTROCAUTERY DETECTOR | Nicolet Biomedical, Inc. | 2002-04-17 | 23 | 0 |
| K011818 | STERILE EMG ELECTRODES | Nicolet Biomedical, Inc. | 2001-09-06 | 87 | 0 |
| K011823 | BIOREHAB SYSTEM | Nicolet Biomedical, Inc. | 2001-09-06 | 87 | 0 |
| K010019 | STERILE SUBDERMAL NEEDLE ELECTRODES | Nicolet Biomedical, Inc. | 2001-03-19 | 76 | 1 |
| K991054 | BRAVO MULTI-MODALITY SYSTEM | Nicolet Biomedical, Inc. | 1999-11-03 | 218 | 4 |
| K971331 | SATELLITE | Nicolet Biomedical, Inc. | 1997-06-25 | 76 | 0 |
| K950270 | NMI SOFTWARE | Nicolet Biomedical, Inc. | 1995-05-15 | 112 | 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