Product code LHC
- Device name
- Warmer, Irrigation Solution
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.5950
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K153713 | Getinge Series Warming Cabinet | Getinge Sourcing, LLC | 2016-06-07 |
| K152522 | ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes | Ecolab, Inc. | 2016-01-15 |
| K150190 | IntraTemp Solution Warmer | Ecolab, Inc. | 2015-02-26 |
| K142173 | NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE | Ecolab, Inc. | 2014-12-30 |
| K142080 | NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED | Ecolab, Inc. | 2014-08-28 |
| K083417 | INTRATEMP SOLUTION WARMER | C Change Surgical, LLC | 2009-01-13 |
| K080609 | SWC/DWC WARMING CABINETS | Mac Medical | 2008-06-13 |
| K051819 | C CHANGE SOLUTION WARMER | C Change Surgical, LLC | 2005-08-15 |
| K023282 | ORS-3000LD | O.R. Solutions, Inc. | 2002-11-13 |
| K023283 | 1075LD HUSH-SLUSH | O.R. Solutions, Inc. | 2002-11-13 |
| K021288 | ORS-1000LD | O.R. Solutions, Inc. | 2002-06-27 |
| K021289 | WARMER 2000LD | O.R. Solutions, Inc. | 2002-06-26 |
| K002859 | SSW-STERILE SOLUTION WARMER | Kmi Kolster Methods, Inc. | 2000-11-16 |
| K965136 | UROSURGE UROTHERM FLUID WARMING SYSTEM | Princeton Regulatory Assoc. | 1998-10-16 |
| K971117 | WARMETTE | Olympic Medical Corp. | 1997-08-22 |
| K951300 | NEZHAT-DORSEY THERMAL RETENTION SYSTEM | American Hydro-Surgical Instruments, Inc. | 1995-06-20 |
| K932538 | CABOT MEDICAL IRRIGATION FLUID WARMER SETS | Cabot Medical Corp. | 1994-02-22 |
| K933726 | MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM | Augustine Medical, Inc. | 1994-01-28 |
| K921633 | ORS-2000 SERIES | Mnlase, Inc. | 1992-06-02 |
| K880876 | C-STAT/1000 | Sonne Medical, Inc. | 1988-05-20 |
| K880252 | THERMAL-PAK MODEL SW 1000 | Micro Tek Engineering | 1988-02-10 |
| K833944 | STERILE SOLUTION WARMER | National Fabtronix, Inc. | 1984-01-25 |
| K832642 | ALPHA-I | Johnson Flexgroup | 1983-11-21 |
| K811524 | AQUACADE | Respiratory Care, Inc. | 1981-07-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00748426146932 | Medline-Microtek | Microtek Medical LLC | 2026-05-20 |
| 00748426146925 | Medline-Microtek | Microtek Medical LLC | 2026-05-20 |
| 00748426146802 | Medline-Microtek | Microtek Medical LLC | 2026-05-20 |
| 00748426137855 | Medline-Microtek | Microtek Medical LLC | 2025-11-05 |
| 00748426143146 | Medline-Microtek | Microtek Medical LLC | 2025-10-14 |
| 00748426143153 | Medline-Microtek | Microtek Medical LLC | 2025-10-14 |
| 00748426143160 | Medline-Microtek | Microtek Medical LLC | 2025-10-14 |
| 00748426143177 | Medline-Microtek | Microtek Medical LLC | 2025-10-14 |
| 00748426143184 | Medline-Microtek | Microtek Medical LLC | 2025-10-14 |
| 00748426143191 | Medline-Microtek | Microtek Medical LLC | 2025-10-14 |
| 00748426143306 | Medline-Microtek | Microtek Medical LLC | 2025-10-14 |
| 00748426143313 | Medline-Microtek | Microtek Medical LLC | 2025-10-14 |
| 00748426143320 | Medline-Microtek | Microtek Medical LLC | 2025-10-14 |
| 00748426143139 | Medline-Microtek | Microtek Medical LLC | 2025-10-08 |
| 00748426140497 | Medline-Microtek | Microtek Medical LLC | 2025-04-08 |
| 10680651517439 | Halyard | Avanos Medical, Inc. | 2022-04-13 |
| 10680651517422 | Halyard | Avanos Medical, Inc. | 2022-04-13 |
| 00850038811006 | Warming Cabinet | Blickman Industries, LLC | 2022-04-11 |
| 00850038811013 | Warming Cabinet | Blickman Industries, LLC | 2022-04-11 |
| 00850038811020 | Warming Cabinet | Blickman Industries, LLC | 2022-04-11 |
| 00850038811037 | Warming Cabinet | Blickman Industries, LLC | 2022-04-11 |
| 00850038811044 | Warming Cabinet | Blickman Industries, LLC | 2022-04-11 |
| 00850038811051 | Warming Cabinet | Blickman Industries, LLC | 2022-04-11 |
| 00850038811068 | Warming Cabinet | Blickman Industries, LLC | 2022-04-11 |
| 00850038811075 | Warming Cabinet | Blickman Industries, LLC | 2022-04-11 |
| 00850038811082 | Warming Cabinet | Blickman Industries, LLC | 2022-04-11 |
| 00850038811099 | Warming Cabinet | Blickman Industries, LLC | 2022-04-11 |
| 00850038811105 | Warming Cabinet | Blickman Industries, LLC | 2022-04-11 |
| 00850038811112 | Warming Cabinet | Blickman Industries, LLC | 2022-04-11 |
| SWC2430364B | WARMER, SINGLE CHAMBER | M.A.C. MEDICAL INC. | 2017-02-13 |