Atlas FDA

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

Advanced Instrumentations, Inc. — Predicate Candidate Screening

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

69 daysmedian FDA review time
195 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemAdvanced Instrumentations, Inc.2017-12-01670
K172055DUS-7000 Digital Color Doppler Ultrasound SystemAdvanced Instrumentations, Inc.2017-08-31560
K141194FM-3000 FETAL MONITORAdvanced Instrumentations, Inc.2014-11-191950
K132077PATIENT MONITORAdvanced Instrumentations, Inc.2014-04-232920
K132059DIAGNOSTIC ULTRASOUND SYSTEMAdvanced Instrumentations, Inc.2013-10-251140
K123048PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PROAdvanced Instrumentations, Inc.2013-01-111050
K120075AM-6000 ANESTHESIA MACHINEAdvanced Instrumentations, Inc.2012-01-26160
K112317FM-9000 PLUS FETAL AND MATERNAL MONITORAdvanced Instrumentations, Inc.2011-12-211320
K112529TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLERAdvanced Instrumentations, Inc.2011-10-27570
K112022DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING Advanced Instrumentations, Inc.2011-09-22690
K111934PD-100 SERIES ULTRASONIC POCKET DOPPLERAdvanced Instrumentations, Inc.2011-09-22760
K112187FM-1000 PLUS FETAL MONITORAdvanced Instrumentations, Inc.2011-09-21540
K112159CMS-1000FM CENTRAL MONITORING SYSTEMAdvanced Instrumentations, Inc.2011-09-21560
K111805ECG SERIES ELECTROCARDIOGRAPHAdvanced Instrumentations, Inc.2011-08-24580
K112135ECG-6 SERIES ELECTROCARDIOGRAPHAdvanced Instrumentations, Inc.2011-08-05100
K082887PM-1000F+PATIENT MONITORAdvanced Instrumentations, Inc.2009-01-161080

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