Cns, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Cns, Inc.” (first 1984, latest 1996), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 108 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 |
|---|---|---|---|
| LWF | Dilator, Nasal | 4 | 4 |
| GWS | Analyzer, Spectrum, Electroencephalogram Signal | 3 | 3 |
| BXO | Transducer, Gas Pressure | 1 | 1 |
| BZG | Spirometer, Diagnostic | 1 | 1 |
| BZQ | Monitor, Breathing Frequency | 1 | 1 |
| GWF | Stimulator, Electrical, Evoked Response | 1 | 1 |
| GWL | Amplifier, Physiological Signal | 1 | 1 |
| GWQ | Full-Montage Standard Electroencephalograph | 1 | 1 |
| MNR | Ventilatory Effort Recorder | 1 | 1 |
Review panels
- Neurology (6)
- Anesthesiology (4)
- Ear, Nose and Throat (4)
Most recent Cns, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955711 | BREATHE RIGHT NASAL STRIP | LWF | 1996-05-30 | 164 |
| K954914 | BREATHE RIGHT NASAL STRIP | LWF | 1996-02-27 | 124 |
| K953772 | BREATHE RIGHT NASAL STRIP | LWF | 1995-10-20 | 67 |
| K950273 | SLEEP TEST(TM) | MNR | 1995-09-19 | 239 |
| K921220 | BREATHE RIGHT | LWF | 1993-10-07 | 573 |
| K912436 | AM-PAK | GWL | 1991-10-18 | 137 |
| K904432 | SLEEP I/T-5 AND SLEEP I/T-8 | BZQ | 1991-07-10 | 285 |
| K910452 | RESPI-PAK RT-PAK | BZG | 1991-04-16 | 74 |
| K901549 | CNS SATELLITE 100, 200, 1000, 2000 ELECTROENCE. | GWQ | 1990-10-24 | 204 |
| K897107 | POLY G PHYSIOLOGICAL DATA RECORDER | BXO | 1990-03-12 | 81 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cns, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Cns, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Cns, Inc.” (first 1984, latest 1996), across 9 product codes in 3 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 Cns, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cns, Inc. is 108 days.
Which FDA product codes appear under Cns, Inc.?
The most frequent FDA product codes under this applicant name are LWF (Dilator, Nasal, 4); GWS (Analyzer, Spectrum, Electroencephalogram Signal, 3); BXO (Transducer, Gas Pressure, 1).
Next steps
- See all 14 Cns, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LWF, Cns, 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.