Product Code: LHC FDA class 1 21 CFR 890.5950

Warmer, Irrigation Solution

Physical Medicine

An irrigation solution warmer is a device used to heat saline or other irrigation fluids to a physiologically appropriate temperature before their use in surgical or physical medicine procedures, reducing patient discomfort and the risk of hypothermia during irrigation. The device is FDA Class 1, the lowest risk category, subject only to general controls and not requiring premarket notification. It carries product code LHC and is regulated under 21 CFR 890.5950 within the Physical Medicine specialty. No special flags apply to this device.

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FEI Numbers

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Basic Information

Product Code: LHC
Device Class: FDA class 1
Regulation Number: 890.5950
Medical Specialty: Physical Medicine
Review Panel: HO
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 24 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K153713	Getinge Series Warming Cabinet	Jun 07, 2016	Substantially Equivalent	Getinge Sourcing, LLC
K152522	ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes	Jan 15, 2016	Substantially Equivalent	Ecolab, Inc.
K150190	IntraTemp Solution Warmer	Feb 26, 2015	Substantially Equivalent	Ecolab, Inc.
K142173	NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE	Dec 30, 2014	Substantially Equivalent	Ecolab, Inc.
K142080	NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED	Aug 28, 2014	Substantially Equivalent	Ecolab, Inc.
K083417	INTRATEMP SOLUTION WARMER	Jan 13, 2009	Substantially Equivalent	C Change Surgical, LLC
K080609	SWC/DWC WARMING CABINETS	Jun 13, 2008	Substantially Equivalent	Mac Medical
K051819	C CHANGE SOLUTION WARMER	Aug 15, 2005	Substantially Equivalent	C Change Surgical, LLC
K023283	1075LD HUSH-SLUSH	Nov 13, 2002	Substantially Equivalent	O.R. Solutions, Inc.
K023282	ORS-3000LD	Nov 13, 2002	Substantially Equivalent	O.R. Solutions, Inc.
K021288	ORS-1000LD	Jun 27, 2002	Substantially Equivalent	O.R. Solutions, Inc.
K021289	WARMER 2000LD	Jun 26, 2002	Substantially Equivalent	O.R. Solutions, Inc.
K002859	SSW-STERILE SOLUTION WARMER	Nov 16, 2000	Substantially Equivalent	Kmi Kolster Methods, Inc.
K965136	UROSURGE UROTHERM FLUID WARMING SYSTEM	Oct 16, 1998	Substantially Equivalent	Princeton Regulatory Assoc.
K971117	WARMETTE	Aug 22, 1997	Substantially Equivalent	Olympic Medical Corp.
K951300	NEZHAT-DORSEY THERMAL RETENTION SYSTEM	Jun 20, 1995	Substantially Equivalent	American Hydro-Surgical Instruments, Inc.
K932538	CABOT MEDICAL IRRIGATION FLUID WARMER SETS	Feb 22, 1994	Substantially Equivalent	Cabot Medical Corp.
K933726	MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM	Jan 28, 1994	Substantially Equivalent	Augustine Medical, Inc.
K921633	ORS-2000 SERIES	Jun 02, 1992	Substantially Equivalent	Mnlase, Inc.
K880876	C-STAT/1000	May 20, 1988	Substantially Equivalent	Sonne Medical, Inc.
K880252	THERMAL-PAK MODEL SW 1000	Feb 10, 1988	Substantially Equivalent	Micro Tek Engineering
K833944	STERILE SOLUTION WARMER	Jan 25, 1984	Substantially Equivalent	National Fabtronix, Inc.
K832642	ALPHA-I	Nov 21, 1983	Substantially Equivalent	Johnson Flexgroup
K811524	AQUACADE	Jul 01, 1981	Substantially Equivalent	Respiratory Care, Inc.