Grass-Telefactor Product Group: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Grass-Telefactor Product Group” (first 1986, latest 1999), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 78 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 |
|---|---|---|---|
| OLV | Standard Polysomnograph With Electroencephalograph | 4 | 4 |
| GWQ | Full-Montage Standard Electroencephalograph | 3 | 3 |
| EEG | Heat Source For Bleaching Teeth | 1 | 1 |
| GWK | Conditioner, Signal, Physiological | 1 | 1 |
| GWS | Analyzer, Spectrum, Electroencephalogram Signal | 1 | 1 |
| GYE | Encephalogram Telemetry System | 1 | 1 |
| OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph | 1 | 1 |
Review panels
Most recent Grass-Telefactor Product Group 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992291 | H20- TETHERED OPTION | OLV | 1999-08-06 | 30 |
| K974583 | DEEGLITE | OLV | 1998-06-09 | 203 |
| K974587 | H2O | OLV | 1998-03-09 | 90 |
| K972202 | DEEG-LITE | GWQ | 1997-07-23 | 42 |
| K925838 | TELEFACTOR D/EEG-32 | GWQ | 1993-04-30 | 163 |
| K884937 | BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING | EEG | 1989-04-14 | 137 |
| K870432 | A1-A2 AMBULATORY EEG CASSETTE RECORDER | GWQ | 1987-05-08 | 94 |
| K871480 | STD-228 SPECTRAL TREND DISPLAY | GWS | 1987-05-01 | 17 |
| K870450 | SZAC-16 SEIZURE ANALYSIS COMPUTER | OMB | 1987-04-08 | 64 |
| K870381 | DD-VCR-64 | GWK | 1987-03-25 | 55 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Grass-Telefactor Product Group.
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.
- Grass-Telefactor Divison (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Grass-Telefactor Product Group?
FDA lists 12 510(k) clearances under the applicant name “Grass-Telefactor Product Group” (first 1986, latest 1999), across 7 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 Grass-Telefactor Product Group?
The median time from FDA receipt to decision across 510(k)s cleared under the name Grass-Telefactor Product Group is 78 days.
Which FDA product codes appear under Grass-Telefactor Product Group?
The most frequent FDA product codes under this applicant name are OLV (Standard Polysomnograph With Electroencephalograph, 4); GWQ (Full-Montage Standard Electroencephalograph, 3); EEG (Heat Source For Bleaching Teeth, 1).
Next steps
- See all 12 Grass-Telefactor Product Group clearances with predicates and recalls
- Run predicate analysis for product code OLV, Grass-Telefactor Product Group'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.