Stellate Systems: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Stellate Systems” (first 1991, latest 2011), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 76 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 |
|---|---|---|---|
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | 2 | 2 |
| OLV | Standard Polysomnograph With Electroencephalograph | 2 | 2 |
| GWQ | Full-Montage Standard Electroencephalograph | 1 | 1 |
| GWS | Analyzer, Spectrum, Electroencephalogram Signal | 1 | 1 |
| OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph | 1 | 1 |
Review panels
- Neurology (7)
Most recent Stellate Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K083577 | HARMONIE SYSTEM | GWQ | 2011-08-29 | 999 |
| K013450 | NOTTA AMBULATORY RECORDER | OLV | 2002-01-14 | 89 |
| K010728 | HARMONE-SCHWARZER EEG SYSTEM | OLV | 2001-05-21 | 70 |
| K982351 | LUNA | OLT | 1998-07-29 | 23 |
| K955577 | ECLIPSE VERSION 3.0 | OLT | 1996-09-20 | 317 |
| K960273 | HARMONIE SENSA | OMB | 1996-04-04 | 76 |
| K912938 | RHYTHM | GWS | 1991-07-30 | 25 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2009-04-16.
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 Stellate Systems?
FDA lists 7 510(k) clearances under the applicant name “Stellate Systems” (first 1991, latest 2011), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Stellate Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stellate Systems is 76 days.
Which FDA product codes appear under Stellate Systems?
The most frequent FDA product codes under this applicant name are OLT (Non-Normalizing Quantitative Electroencephalograph Software, 2); OLV (Standard Polysomnograph With Electroencephalograph, 2); GWQ (Full-Montage Standard Electroencephalograph, 1).
Next steps
- See all 7 Stellate Systems clearances with predicates and recalls
- Run predicate analysis for product code OLT, Stellate Systems'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.