Astro-Med, Inc.: FDA clearances and approvals
Astro-Med, Inc. has 13 FDA 510(k) clearances (first 1989, latest 2008), across 10 product codes in 2 review panels. Median 510(k) review time: 90 days.
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 |
|---|---|---|---|
| DRR | Amplifier And Signal Conditioner, Biopotential | 2 | 2 |
| DSF | Recorder, Paper Chart | 2 | 2 |
| OLV | Standard Polysomnograph With Electroencephalograph | 2 | 2 |
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | 1 | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
| GWK | Conditioner, Signal, Physiological | 1 | 1 |
| GWL | Amplifier, Physiological Signal | 1 | 1 |
| GWQ | Full-Montage Standard Electroencephalograph | 1 | 1 |
| OMA | Amplitude-Integrated Electroencephalograph | 1 | 1 |
Review panels
- Cardiovascular (7)
- Neurology (6)
Most recent Astro-Med, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K081551 | TWIN NEUROTRAC-III | OMA | 2008-12-24 | 204 |
| K050425 | AURA-PSG | OLV | 2005-10-20 | 244 |
| K033978 | ADAM | GWQ | 2004-02-18 | 57 |
| K970951 | GRASS BRAINWAVE SOFTWARE | OLV | 1997-05-19 | 66 |
| K963669 | GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM | GWL | 1996-12-12 | 90 |
| K934644 | K3 SYSTEM | DRT | 1994-11-01 | 398 |
| K912929 | DASH IV | DSF | 1991-08-13 | 39 |
| K896164 | ASC-954 INTEGRATOR AMPLIFIER | GWK | 1990-01-22 | 90 |
| K894295 | ASTRO-MED ASC-951 PRESSURE PROCESSOR | DRQ | 1990-01-18 | 209 |
| K894736 | MT96000 PAPER CHART RECORDER | DSF | 1989-12-13 | 139 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Astro-Med, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Astro-Med, Inc. have?
Astro-Med, Inc. has 13 FDA 510(k) clearances (first 1989, latest 2008), across 10 product codes in 2 review panels.
How long does FDA take to clear Astro-Med, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Astro-Med, Inc.'s cleared 510(k)s is 90 days.
What devices does Astro-Med, Inc. make?
Its most frequent FDA product codes are DRR (Amplifier And Signal Conditioner, Biopotential, 2); DSF (Recorder, Paper Chart, 2); OLV (Standard Polysomnograph With Electroencephalograph, 2).
Has Astro-Med, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Astro-Med, Inc. Related entities may recall under other names.
Next steps
- See all 13 Astro-Med, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRR, Astro-Med, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.