Grass Instrument Co.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Grass Instrument Co.” (first 1977, latest 2002), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 74 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 | 2 | 2 |
| GWE | Stimulator, Photic, Evoked Response | 1 | 1 |
| GWJ | Stimulator, Auditory, Evoked Response | 1 | 1 |
| GWK | Conditioner, Signal, Physiological | 1 | 1 |
| JXE | Device, Nerve Conduction Velocity Measurement | 1 | 1 |
Review panels
- Neurology (6)
Most recent Grass Instrument Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021807 | GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM | OLV | 2002-08-29 | 87 |
| K994142 | GRASS TS3201/6401 EEG AMPLIFIER SYSTEM | OLV | 2000-03-06 | 89 |
| K844216 | GRASS MODEL NL FACIAL NERVE LOCATOR & MONITOR | JXE | 1985-01-18 | 79 |
| K812061 | MODEL S10VS VISUAL STIMULATOR | GWE | 1981-08-20 | 30 |
| K810539 | MODEL S10CTCM AUDITORY STIMULATOR | GWJ | 1981-03-17 | 18 |
| K771742 | EVOKED RESPONSE SYS., MODEL 10 | GWK | 1977-11-22 | 68 |
Recalls
openFDA lists no recalls under a recalling firm named Grass Instrument Co..
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 Product Group (12 510(k)s)
- Grass Technologies, an Astro-Med, Inc. Product Gro (1 510(k)s)
- Grass-Telefactor Divison (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Grass Instrument Co.?
FDA lists 6 510(k) clearances under the applicant name “Grass Instrument Co.” (first 1977, latest 2002), 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 Grass Instrument Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Grass Instrument Co. is 74 days.
Which FDA product codes appear under Grass Instrument Co.?
The most frequent FDA product codes under this applicant name are OLV (Standard Polysomnograph With Electroencephalograph, 2); GWE (Stimulator, Photic, Evoked Response, 1); GWJ (Stimulator, Auditory, Evoked Response, 1).
Next steps
- See all 6 Grass Instrument Co. clearances with predicates and recalls
- Run predicate analysis for product code OLV, Grass Instrument Co.'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.