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

Millar Instruments, Inc. — Predicate Candidate Screening

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

95 daysmedian FDA review time
280 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K112323CARDIA-CATHMillar Instruments, Inc.2011-10-18670
K093111MIKRO-CATH, MODEL 825-0101Millar Instruments, Inc.2010-01-05960
K013205MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000Millar Instruments, Inc.2002-07-022800
K993694MIKRO-TIP ANGIOGRAPHIC CATHETERMillar Instruments, Inc.2000-03-011203
K952773MIKRO-TIP ANGIOGRAPHIC CATHETERMillar Instruments, Inc.1995-11-071442
K935166FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCERMillar Instruments, Inc.1994-08-052820
K915775MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRANMillar Instruments, Inc.1992-04-201180
K896264MILLAR MIKRO-TIP DOPPLER CATHETERMillar Instruments, Inc.1990-01-24850
K895721MILLAR MIKRO-TIP PULSE TRANSDUCERMillar Instruments, Inc.1989-12-07730
K883651MILLAR MIKRO-TIP CATHETER PRESSURE TRANSDUCERMillar Instruments, Inc.1988-11-18840
K860766MILLAR PULSED DOPPLER VELOCIMETERMillar Instruments, Inc.1986-07-291480
K853138MILLAR MIKRO-TIP DOPPLER CATHETERMillar Instruments, Inc.1985-10-29950
K842150TRANSDUCER-MONITOR INTERFACINGMillar Instruments, Inc.1984-10-261490
K830909MIKRO-TIP CATH. PRESSURE TRANSDUCERMillar Instruments, Inc.1983-04-18280
K823434MIKRO-TIP CATHETER PRESSURE TRANSDUCERMillar Instruments, Inc.1982-11-30140
K812944MILLAR MIKRO-TIP CATHETER PRESSURE TRAN.Millar Instruments, Inc.1981-11-16270
K802830MILLAR MIKRO-TIP CATHETER PHONOTRANSMillar Instruments, Inc.1980-12-10300
K792177MILLAR MIKRO-TIP CATHETER TRANSDUCERMillar Instruments, Inc.1979-11-15160

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