Nicolet Biomedical, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under 2 spellings of the applicant name “Nicolet Biomedical, Inc.” (first 1995, latest 2003), across 15 product codes in 5 review panels. Median 510(k) review time under this name: 86 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| GWQ | Full-Montage Standard Electroencephalograph | 2 | 2 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | 2 |
| JAF | Monitor, Ultrasonic, Nonfetal | 2 | 2 |
| ETN | Stimulator, Nerve | 1 | 1 |
| EWO | Audiometer | 1 | 1 |
| GXY | Electrode, Cutaneous | 1 | 1 |
| GXZ | Electrode, Needle | 1 | 1 |
| GYC | Electrode, Cortical | 1 | 1 |
| HCC | Device, Biofeedback | 1 | 1 |
| HGM | System, Monitoring, Perinatal | 1 | 1 |
Plus 5 more product codes.
Review panels
- Neurology (9)
- Radiology (5)
- Ear, Nose and Throat (2)
- Cardiovascular (1)
- Obstetrics and Gynecology (1)
Most recent Nicolet Biomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K020754 | NICOLET PIONEER TC8080 | IYN | 2003-04-21 | 410 |
| K021986 | BRAINET | GXY | 2002-08-23 | 66 |
| K021144 | SUBDURAL STRIP ELECTRODE | GYC | 2002-06-24 | 76 |
| K020218 | SNAP EEG MONITOR | OLW | 2002-04-22 | 90 |
| K013281 | VERSALAB APM | HGM | 2002-04-18 | 198 |
| K020955 | NICOLET ELECTROCAUTERY DETECTOR | ETN | 2002-04-17 | 23 |
| K013419 | NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM | LLZ | 2001-12-20 | 66 |
| K011823 | BIOREHAB SYSTEM | HCC | 2001-09-06 | 87 |
| K011818 | STERILE EMG ELECTRODES | IKT | 2001-09-06 | 87 |
| K011135 | GSI AUDERA | EWO | 2001-07-26 | 104 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nicolet Biomedical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Nicolet Biomedical, Inc. (10)
- Nicolet Biomedical (8)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Nicolet Biomedical Instruments (26 510(k)s)
- Nicolet Instrument Corp. (13 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nicolet Biomedical, Inc.?
FDA lists 18 510(k) clearances under 2 spellings of the applicant name “Nicolet Biomedical, Inc.” (first 1995, latest 2003), across 15 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Nicolet Biomedical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nicolet Biomedical, Inc. is 86 days.
Which FDA product codes appear under Nicolet Biomedical, Inc.?
The most frequent FDA product codes under this applicant name are GWQ (Full-Montage Standard Electroencephalograph, 2); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 2); JAF (Monitor, Ultrasonic, Nonfetal, 2).
Next steps
- See all 18 Nicolet Biomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GWQ, Nicolet Biomedical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.