Nicolet Instrument Corp.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Nicolet Instrument Corp.” (first 1988, latest 1993), across 10 product codes in 2 review panels. Median 510(k) review time under this name: 139 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 |
|---|---|---|---|
| GWF | Stimulator, Electrical, Evoked Response | 2 | 2 |
| GWQ | Full-Montage Standard Electroencephalograph | 2 | 2 |
| IKN | Electromyograph, Diagnostic | 2 | 2 |
| ESD | Hearing Aid, Air-Conduction, Prescription | 1 | 1 |
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | 1 | 1 |
| GWJ | Stimulator, Auditory, Evoked Response | 1 | 1 |
| GWK | Conditioner, Signal, Physiological | 1 | 1 |
| GWN | Nystagmograph | 1 | 1 |
| GWS | Analyzer, Spectrum, Electroencephalogram Signal | 1 | 1 |
| GYC | Electrode, Cortical | 1 | 1 |
Review panels
- Neurology (11)
- Ear, Nose and Throat (2)
Most recent Nicolet Instrument Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K921138 | NICOLET ULTRASOM ACQUISITION STATION | GWQ | 1993-05-14 | 430 |
| K923315 | NICOLET ARK SYSTEM | GWF | 1992-11-23 | 139 |
| K921927 | NICOLET VOYAGEUR | GWQ | 1992-11-05 | 195 |
| K915652 | NICOLET PORATBLE SPIRIT SYSTEM | GWF | 1992-02-07 | 51 |
| K905632 | NICOLET MAPLELEAF SYSTEM | GWJ | 1991-06-07 | 172 |
| K897154 | NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE | ESD | 1990-04-30 | 125 |
| K894629 | NICOLET BEAM II SYSTEM | GWS | 1990-03-09 | 228 |
| K896477 | NICOLET REAL EAR ANALYZER | ETW | 1990-02-08 | 87 |
| K883781 | NICOLET NEUROPORT/ACE SYSTEM | IKN | 1989-06-05 | 272 |
| K890495 | NICOLET VIKING II SYSTEM | IKN | 1989-03-16 | 43 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nicolet Instrument Corp..
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.
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 Biomedical, Inc. (18 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nicolet Instrument Corp.?
FDA lists 13 510(k) clearances under the applicant name “Nicolet Instrument Corp.” (first 1988, latest 1993), across 10 product codes in 2 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 Instrument Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nicolet Instrument Corp. is 139 days.
Which FDA product codes appear under Nicolet Instrument Corp.?
The most frequent FDA product codes under this applicant name are GWF (Stimulator, Electrical, Evoked Response, 2); GWQ (Full-Montage Standard Electroencephalograph, 2); IKN (Electromyograph, Diagnostic, 2).
Next steps
- See all 13 Nicolet Instrument Corp. clearances with predicates and recalls
- Run predicate analysis for product code GWF, Nicolet Instrument Corp.'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.