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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Astro-Med, Inc. — Predicate Candidate Screening

13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

90 daysmedian FDA review time
244 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K081551TWIN NEUROTRAC-IIIAstro-Med, Inc.2008-12-242040
K050425AURA-PSGAstro-Med, Inc.2005-10-202440
K033978ADAMAstro-Med, Inc.2004-02-18570
K970951GRASS BRAINWAVE SOFTWAREAstro-Med, Inc.1997-05-19660
K963669GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEMAstro-Med, Inc.1996-12-12900
K934644K3 SYSTEMAstro-Med, Inc.1994-11-013980
K912929DASH IVAstro-Med, Inc.1991-08-13390
K896164ASC-954 INTEGRATOR AMPLIFIERAstro-Med, Inc.1990-01-22900
K894295ASTRO-MED ASC-951 PRESSURE PROCESSORAstro-Med, Inc.1990-01-182090
K894736MT96000 PAPER CHART RECORDERAstro-Med, Inc.1989-12-131390
K894735ASC-952 PHYSIOLOGICAL AMPLIFIERAstro-Med, Inc.1989-09-18530
K894161ASC-950 ECG AMPLIFIERAstro-Med, Inc.1989-08-03500
K892067MT9000 CHART RECORDERAstro-Med, Inc.1989-06-05670

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