Physiometrix, Inc.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Physiometrix, Inc.” (first 1992, latest 2005), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 85 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 |
|---|---|---|---|
| GXY | Electrode, Cutaneous | 7 | 7 |
| GWQ | Full-Montage Standard Electroencephalograph | 5 | 5 |
| OLW | Index-Generating Electroencephalograph Software | 4 | 4 |
| DRX | Electrode, Electrocardiograph | 2 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| GYB | Media, Electroconductive | 1 | 1 |
| IKD | Cable, Electrode | 1 | 1 |
Review panels
- Neurology (17)
- Cardiovascular (2)
- General and Plastic Surgery (2)
- Physical Medicine (1)
Most recent Physiometrix, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K051874 | SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET | OLW | 2005-09-02 | 53 |
| K033999 | SEDLINE WITH FRONTAL PSI | OLW | 2004-02-06 | 44 |
| K020670 | MODEL 4310 PSARRAY2 EEG ELECTRODE | GXY | 2002-10-08 | 221 |
| K020671 | PSA4000 EEG MONITOR WITH FRONTAL PSI | OLW | 2002-10-04 | 217 |
| K001069 | MODEL 4000 EEG MONITOR WITH PSI (PSA4000) | OLW | 2000-06-30 | 88 |
| K001055 | MODEL 4300 PSARRAY EEG ELECTRODE SET | GXY | 2000-05-11 | 38 |
| K970942 | MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM | GWQ | 1997-06-02 | 80 |
| K970694 | MODEL 1700, HYDRO PREP | GYB | 1997-05-14 | 78 |
| K962447 | EQUINOX DIGITAL EEG SYSTEM | GWQ | 1996-12-12 | 171 |
| K962157 | MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM | GWQ | 1996-11-25 | 174 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Physiometrix, 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 Physiometrix, Inc.?
FDA lists 22 510(k) clearances under the applicant name “Physiometrix, Inc.” (first 1992, latest 2005), across 7 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 Physiometrix, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Physiometrix, Inc. is 85 days.
Which FDA product codes appear under Physiometrix, Inc.?
The most frequent FDA product codes under this applicant name are GXY (Electrode, Cutaneous, 7); GWQ (Full-Montage Standard Electroencephalograph, 5); OLW (Index-Generating Electroencephalograph Software, 4).
Next steps
- See all 22 Physiometrix, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GXY, Physiometrix, 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, 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.