Atlas FDA

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

Infrasonics Corp. — Predicate Candidate Screening

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

126 daysmedian FDA review time
414 days90th percentile
20clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K943106ADULT VENTILATORInfrasonics Corp.1995-12-285470
K952878OXY/STAR LOW FLOW BLENDERInfrasonics Corp.1995-09-25940
K934753STAR BREATHING CIRCUITSInfrasonics Corp.1993-10-27230
K922654VENTILATOR ADULT STAR MODIFICATIONInfrasonics Corp.1992-12-011810
K923704INFANT STAR SERIES 500Infrasonics Corp.1992-10-22900
K922477MODEL 105 VENTILATOR, MODIFICATIONInfrasonics Corp.1992-08-24890
K920954AIR STARInfrasonics Corp.1992-08-031590
K911804INFRASONICS VENTILATOR ADULT STAR, MODIFICATIONInfrasonics Corp.1992-06-114140
K913972STAR SYNC, MODIFICATIONInfrasonics Corp.1992-01-091260
K905272ADULT STAR, MODIFICATIONInfrasonics Corp.1991-01-30680
K896825TRANSCUTANEOUS ELECTRONIC NERVE STIMULATORInfrasonics Corp.1990-11-163460
K895963MODIFIED STAR CALCInfrasonics Corp.1990-03-161560
K884521STAR SYNCInfrasonics Corp.1989-06-082240
K875027STAR CALCInfrasonics Corp.1988-08-162530
K872466ADULT STARInfrasonics Corp.1988-07-083810
K873395HOYER SOLVETInfrasonics Corp.1987-10-20570
K853487PATIENT BREATHING CIRCUITInfrasonics Corp.1985-09-06170
K842580ACCESSORY FOR ADULT VOL. VENTILATORInfrasonics Corp.1984-08-24520
K843036PATIENT BREATHING CIRCUITInfrasonics Corp.1984-08-15130
K840865INFANT STAR VENTILATORInfrasonics Corp.1984-04-30630

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