Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Grass Instrument Co. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
89 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K021807 | GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM | Grass Instrument Co. | 2002-08-29 | 87 | 0 |
| K994142 | GRASS TS3201/6401 EEG AMPLIFIER SYSTEM | Grass Instrument Co. | 2000-03-06 | 89 | 0 |
| K844216 | GRASS MODEL NL FACIAL NERVE LOCATOR & MONITOR | Grass Instrument Co. | 1985-01-18 | 79 | 0 |
| K812061 | MODEL S10VS VISUAL STIMULATOR | Grass Instrument Co. | 1981-08-20 | 30 | 0 |
| K810539 | MODEL S10CTCM AUDITORY STIMULATOR | Grass Instrument Co. | 1981-03-17 | 18 | 0 |
| K771742 | EVOKED RESPONSE SYS., MODEL 10 | Grass Instrument Co. | 1977-11-22 | 68 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda