Atlas FDA

MQS

18 FDA 510(k) clearances · Product code

191 daysmedian time to decision
531 days90th percentile
18clearances measured

FDA profile

Official device name
System, Hemodialysis, Access Recirculation Monitoring
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5820
Medical specialty
Gastroenterology, Urology
Flags
Life-sustaining
Adverse events (MAUDE)
2006: 154 · 2007: 68 · 2008: 6 · 2009: 21 · 2010: 10 · 2012: 5
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
PhySoftAMS® (K232283)Physician Software Systems, LLC2023-12-14
Dosis SAM (K180410)Dosis, Inc.2019-01-16
PHYSOFT AMS (K130579)Physicians Software Systems, LLC2013-12-19
VASC-ALERT (K042566)Vasc-Alert, Inc.2004-11-08
TRANSONIC SYRINGE WARMER, MODEL SYR-1000 (K022963)Transonic Systems, Inc.2002-12-04
TRANSONIC FLOW-QC SET MODEL ADT1010 (K021571)Transonic Systems, Inc.2002-08-12
CRIT-LINE MONITOR III (CLM III) (K001763)In-Line Diagnostics Corp.2000-12-20
HP M2376A DEVICE LINK SYSTEM (K993587)Hewlett-Packard Co.2000-01-20
CRIT-LINE MONITOR III (CLM III) (K992227)In-Line Diagnostics Corp.1999-07-30
HP M2376A DEVICE LINK SYSTEM (K984194)Hewlett-Packard Co.1999-04-30
MODIFICATION OF CRIT-LINE MONITOR III (CLM III) (K982412)In-Line Diagnostics Corp.1998-10-09
TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO (K980906)Transonic Systems, Inc.1998-10-06
CRIT-LINE MONITOR (CLMIII) (K972470)In-Line Diagnostics Corp.1997-12-11
HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2) (K960817)Transonic Systems, Inc.1997-02-11
COBE HEMODYNAMIC RECIRCULATION MONITOR (K954003)Cobe Renal Care, Inc.1997-02-06
CRIT-LINE HEMATOCRIT ALERT (MODIFICATION) (K953875)In-Line Diagnostics Corp.1996-07-23
FRESENIUS BLOOD TEMPERATURE MONITOR (K941460)Fresenius USA, Inc.1996-07-03
KNOW-RECIRC (K953551)H&H Control Systems1996-06-21

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Every clearance here is in the API, with alerts when new ones post.