LHC — Warmer, Irrigation Solution Class I
FDA product code LHC covers "Warmer, Irrigation Solution", a Class I medical device regulated under 21 CFR 890.5950. Submissions are reviewed by the Physical Medicine panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LHC
- Device Class
- Class I
- Regulation Number
- 890.5950
- Submission Type
- Review Panel
- HO
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K153713 | getinge sourcing | Getinge Series Warming Cabinet | June 7, 2016 |
| K152522 | ecolab | ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes | January 15, 2016 |
| K150190 | ecolab | IntraTemp Solution Warmer | February 26, 2015 |
| K142173 | ecolab | NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE | December 30, 2014 |
| K142080 | ecolab | NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE | August 28, 2014 |
| K083417 | c change surgical | INTRATEMP SOLUTION WARMER | January 13, 2009 |
| K080609 | mac medical | SWC/DWC WARMING CABINETS | June 13, 2008 |
| K051819 | c change surgical | C CHANGE SOLUTION WARMER | August 15, 2005 |
| K023282 | o.r. solutions | ORS-3000LD | November 13, 2002 |
| K023283 | o.r. solutions | 1075LD HUSH-SLUSH | November 13, 2002 |
| K021288 | o.r. solutions | ORS-1000LD | June 27, 2002 |
| K021289 | o.r. solutions | WARMER 2000LD | June 26, 2002 |
| K002859 | kmi kolster methods | SSW-STERILE SOLUTION WARMER | November 16, 2000 |
| K965136 | princeton regulatory assoc | UROSURGE UROTHERM FLUID WARMING SYSTEM | October 16, 1998 |
| K971117 | olympic medical | WARMETTE | August 22, 1997 |
| K951300 | american hydro-surgical instruments | NEZHAT-DORSEY THERMAL RETENTION SYSTEM | June 20, 1995 |
| K932538 | cabot medical | CABOT MEDICAL IRRIGATION FLUID WARMER SETS | February 22, 1994 |
| K933726 | augustine medical | MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM | January 28, 1994 |
| K921633 | mnlase | ORS-2000 SERIES | June 2, 1992 |
| K880876 | sonne medical | C-STAT/1000 | May 20, 1988 |