LHC · Warmer, Irrigation Solution
Physical Medicine · 21 CFR 890.5950 · Class 1
Overview
| Product Code | LHC |
|---|---|
| Device Name | Warmer, Irrigation Solution |
| Regulation | 21 CFR 890.5950 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
Identification
A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
Recent Cleared Devices (20 of 24)
Showing 20 most recent of 24 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K153713 | Getinge Series Warming Cabinet | Getinge Sourcing, LLC | Jun 7, 2016 | SESE |
| K152522 | ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes | Ecolab, Inc. | Jan 15, 2016 | SESE |
| K150190 | IntraTemp Solution Warmer | Ecolab, Inc. | Feb 26, 2015 | SESE |
| K142173 | NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE | Ecolab, Inc. | Dec 30, 2014 | SESE |
| K142080 | NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED | Ecolab, Inc. | Aug 28, 2014 | SESE |
| K083417 | INTRATEMP SOLUTION WARMER | C Change Surgical, LLC | Jan 13, 2009 | SESE |
| K080609 | SWC/DWC WARMING CABINETS | Mac Medical | Jun 13, 2008 | SESE |
| K051819 | C CHANGE SOLUTION WARMER | C Change Surgical, LLC | Aug 15, 2005 | SESE |
| K023283 | 1075LD HUSH-SLUSH | O.R. Solutions, Inc. | Nov 13, 2002 | SESE |
| K023282 | ORS-3000LD | O.R. Solutions, Inc. | Nov 13, 2002 | SESE |
| K021288 | ORS-1000LD | O.R. Solutions, Inc. | Jun 27, 2002 | SESE |
| K021289 | WARMER 2000LD | O.R. Solutions, Inc. | Jun 26, 2002 | SESE |
| K002859 | SSW-STERILE SOLUTION WARMER | Kmi Kolster Methods, Inc. | Nov 16, 2000 | SESE |
| K965136 | UROSURGE UROTHERM FLUID WARMING SYSTEM | Princeton Regulatory Assoc. | Oct 16, 1998 | SESE |
| K971117 | WARMETTE | Olympic Medical Corp. | Aug 22, 1997 | SESE |
| K951300 | NEZHAT-DORSEY THERMAL RETENTION SYSTEM | American Hydro-Surgical Instruments, Inc. | Jun 20, 1995 | SESE |
| K932538 | CABOT MEDICAL IRRIGATION FLUID WARMER SETS | Cabot Medical Corp. | Feb 22, 1994 | SESE |
| K933726 | MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM | Augustine Medical, Inc. | Jan 28, 1994 | SESE |
| K921633 | ORS-2000 SERIES | Mnlase, Inc. | Jun 2, 1992 | SESE |
| K880876 | C-STAT/1000 | Sonne Medical, Inc. | May 20, 1988 | SESE |
Top Applicants
- Ecolab, Inc. — 4 clearances
- O.R. Solutions, Inc. — 4 clearances
- C Change Surgical, LLC — 2 clearances
- American Hydro-Surgical Instruments, Inc. — 1 clearance
- Augustine Medical, Inc. — 1 clearance
