Atlas FDA

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

Precision Acoustics Ind., Inc. — Predicate Candidate Screening

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

60 daysmedian FDA review time
175 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K943607INTERACOUSTICS HEARING AID ANALYZER MS 40Precision Acoustics Ind., Inc.1994-09-23600
K941920INTERACOUSTICS CLINICAL AUDIOMETERPrecision Acoustics Ind., Inc.1994-09-161490
K942008INTERACOUSTICS AUTOMATIC IMPEDANCE AUDIOMETERPrecision Acoustics Ind., Inc.1994-08-241210
K942007INTERACOUSTICS CLINICAL IMPEDANCE AUDIOMETER AZ26Precision Acoustics Ind., Inc.1994-08-241210
K943066INTERACOUSTICS COMPUTER AUDIOMETER BA 20Precision Acoustics Ind., Inc.1994-08-24570
K943065INTERACOUSTICS CLINICAL AUDIOMETERPrecision Acoustics Ind., Inc.1994-08-17500
K942006INTERACOUSTICS DIAGNOSTIC AUDIOMETERPrecision Acoustics Ind., Inc.1994-06-20560
K941848INTERACOUSTICS. HEARING AID ANALYZERPrecision Acoustics Ind., Inc.1994-05-23390
K930260ACOUSTIC ANALYZER AA30Precision Acoustics Ind., Inc.1993-07-131750

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