Atlas FDA

LHC

24 FDA 510(k) clearances · Product code

71 daysmedian time to decision
179 days90th percentile
24clearances measured

FDA profile

Official device name
Warmer, Irrigation Solution
Device class
Class I (low risk)
Regulation
21 CFR 890.5950
Medical specialty
Physical Medicine
Adverse events (MAUDE)
2008: 5 · 2012: 5 · 2015: 13 · 2016: 69 · 2017: 33 · 2018: 30
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Getinge Series Warming Cabinet (K153713)Getinge Sourcing, LLC2016-06-07
ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes (K152522)Ecolab, Inc.2016-01-15
IntraTemp Solution Warmer (K150190)Ecolab, Inc.2015-02-26
NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE (K142173)Ecolab, Inc.2014-12-30
NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED (K142080)Ecolab, Inc.2014-08-28
INTRATEMP SOLUTION WARMER (K083417)C Change Surgical, LLC2009-01-13
SWC/DWC WARMING CABINETS (K080609)Mac Medical2008-06-13
C CHANGE SOLUTION WARMER (K051819)C Change Surgical, LLC2005-08-15
ORS-3000LD (K023282)O.R. Solutions, Inc.2002-11-13
1075LD HUSH-SLUSH (K023283)O.R. Solutions, Inc.2002-11-13
ORS-1000LD (K021288)O.R. Solutions, Inc.2002-06-27
WARMER 2000LD (K021289)O.R. Solutions, Inc.2002-06-26
SSW-STERILE SOLUTION WARMER (K002859)Kmi Kolster Methods, Inc.2000-11-16
UROSURGE UROTHERM FLUID WARMING SYSTEM (K965136)Princeton Regulatory Assoc.1998-10-16
WARMETTE (K971117)Olympic Medical Corp.1997-08-22
NEZHAT-DORSEY THERMAL RETENTION SYSTEM (K951300)American Hydro-Surgical Instruments, Inc.1995-06-20
CABOT MEDICAL IRRIGATION FLUID WARMER SETS (K932538)Cabot Medical Corp.1994-02-22
MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM (K933726)Augustine Medical, Inc.1994-01-28
ORS-2000 SERIES (K921633)Mnlase, Inc.1992-06-02
C-STAT/1000 (K880876)Sonne Medical, Inc.1988-05-20
THERMAL-PAK MODEL SW 1000 (K880252)Micro Tek Engineering1988-02-10
STERILE SOLUTION WARMER (K833944)National Fabtronix, Inc.1984-01-25
ALPHA-I (K832642)Johnson Flexgroup1983-11-21
AQUACADE (K811524)Respiratory Care, Inc.1981-07-01

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