Nicolet Biomedical Instruments: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Nicolet Biomedical Instruments” (first 1977, latest 1988), across 19 product codes in 4 review panels. Median 510(k) review time under this name: 54 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 |
|---|---|---|---|
| IKN | Electromyograph, Diagnostic | 6 | 6 |
| GWK | Conditioner, Signal, Physiological | 2 | 2 |
| GWQ | Full-Montage Standard Electroencephalograph | 2 | 2 |
| DQC | Phonocardiograph | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| ESD | Hearing Aid, Air-Conduction, Prescription | 1 | 1 |
| ETN | Stimulator, Nerve | 1 | 1 |
| EWO | Audiometer | 1 | 1 |
| GWE | Stimulator, Photic, Evoked Response | 1 | 1 |
| GWF | Stimulator, Electrical, Evoked Response | 1 | 1 |
Plus 9 more product codes.
Review panels
- Neurology (18)
- Ear, Nose and Throat (3)
- Ophthalmic (3)
- Cardiovascular (2)
Most recent Nicolet Biomedical Instruments 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K880573 | MODIFIED NICOLET VIKING SYSTEM | IKN | 1988-03-22 | 41 |
| K873736 | NICOLET DIGITAL TWO PIECE HEARING AID | ESD | 1987-12-08 | 84 |
| K873964 | NICOLET DISPOSABLE PRASS PROBE | ETN | 1987-11-20 | 52 |
| K873535 | NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM | GWQ | 1987-10-26 | 55 |
| K871678 | NICOLET AMP 6R11 SYSTEM | GWL | 1987-07-16 | 79 |
| K862592 | PHOENIX SYSTEM SEVEN. | EWO | 1986-09-16 | 70 |
| K851190 | NYSTAGMOGRAPH EOG/ENG ANALYSES | GWN | 1985-11-27 | 246 |
| K850259 | ELECTROENCEPHALOGRAPH EEG | GWQ | 1985-04-11 | 79 |
| K850108 | EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG | GXY | 1985-04-11 | 91 |
| K850107 | CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE | GXZ | 1985-04-11 | 91 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nicolet Biomedical Instruments.
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, Inc. (18 510(k)s)
- Nicolet Instrument Corp. (13 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nicolet Biomedical Instruments?
FDA lists 26 510(k) clearances under the applicant name “Nicolet Biomedical Instruments” (first 1977, latest 1988), across 19 product codes in 4 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 Instruments?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nicolet Biomedical Instruments is 54 days.
Which FDA product codes appear under Nicolet Biomedical Instruments?
The most frequent FDA product codes under this applicant name are IKN (Electromyograph, Diagnostic, 6); GWK (Conditioner, Signal, Physiological, 2); GWQ (Full-Montage Standard Electroencephalograph, 2).
Next steps
- See all 26 Nicolet Biomedical Instruments clearances with predicates and recalls
- Run predicate analysis for product code IKN, Nicolet Biomedical Instruments'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.