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

Sonosite,Inc. — Predicate Candidate Screening

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

15 daysmedian FDA review time
88 days90th percentile
23clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K113156SONOSITE EDGE ULTRASOUND SYSTEMSonosite,Inc.2011-11-15201
K110645BIO Z CARDIO PROFILE HEMODYNAMIC MONITORSonosite,Inc.2011-06-03910
K102390SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEMSonosite,Inc.2010-11-19880
K093510LUMENVU CATHETER GUIDANCE SYSTEMSonosite,Inc.2010-08-232840
K101757SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SESonosite,Inc.2010-08-12500
K092058SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEMSonosite,Inc.2009-10-02862
K082098SONOSITE MAXX SERIES ULTRASOUND SYSTEMSonosite,Inc.2008-08-25312
K071134SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEMSonosite,Inc.2007-05-08152
K053069SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)Sonosite,Inc.2005-11-16153
K052109SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES)Sonosite,Inc.2005-08-1170
K043559SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SESonosite,Inc.2005-01-12164
K043452TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOSonosite,Inc.2004-12-2160
K033367TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEMSonosite,Inc.2003-11-05150
K030949TITAN HIGH RESOLUTION ULTRASOUND SYSTEMSonosite,Inc.2003-04-07120
K030064ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLYSonosite,Inc.2003-01-22151
K023957SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES)Sonosite,Inc.2002-12-12150
K021628SONOSITE HAND-CARIED UNTRASOUND SYSTEM (POWERSERIES)Sonosite,Inc.2002-05-31140
K014116HAND-CARRIED ULTRASOUND SYSTEMSonosite,Inc.2001-12-2060
K010374SONOSITE HAND-CARRIED ULTRASOUND SYSTEMSonosite,Inc.2001-02-21140
K003399SONOSITE HAND-CARRIED ULTRASOUND SYSTEMSonosite,Inc.2000-11-16150
K994096SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEMSonosite,Inc.1999-12-20170
K990806C1 ULTRASOUND SYSTEMSonosite,Inc.1999-03-26150
K981505COZUMEL DIAGNOSTIC ULTRASOUND SYSTEMSonosite,Inc.1998-05-08140

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