Product code LHC— Physical Medicine
1075LD HUSH-SLUSH
- Classification name
- Warmer, Irrigation Solution
- Device class
- Class 1
- Regulation
- 21 CFR 890.5950
- Advisory panel
- Physical Medicine
- Total cleared
- 24
- First cleared
- Most recent
Market context for product code LHC
FDA has cleared devices under product code LHC between 1981 and 2016, filed by 17 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
last 15 years- 2016
- 2015
- 2014
- 2009
- 2008
- 2005
- 2002
- 2000
- 1998
- 1997
- 1995
- 1994
- 1992
- 1988
- 1984
Top applicants under product code LHC
Recent clearances under product code LHC
- K153713 — Getinge Series Warming Cabinet
- K152522 — ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes
- K150190 — IntraTemp Solution Warmer
- K142173 — NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE
- K142080 — NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED
- K083417 — INTRATEMP SOLUTION WARMER
- K080609 — SWC/DWC WARMING CABINETS
- K051819 — C CHANGE SOLUTION WARMER
- K023282 — ORS-3000LD
- K023283 — 1075LD HUSH-SLUSH
- K021288 — ORS-1000LD
- K021289 — WARMER 2000LD
- K002859 — SSW-STERILE SOLUTION WARMER
- K965136 — UROSURGE UROTHERM FLUID WARMING SYSTEM
- K971117 — WARMETTE
- K951300 — NEZHAT-DORSEY THERMAL RETENTION SYSTEM
- K932538 — CABOT MEDICAL IRRIGATION FLUID WARMER SETS
- K933726 — MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM
- K921633 — ORS-2000 SERIES
- K880876 — C-STAT/1000
- K880252 — THERMAL-PAK MODEL SW 1000
- K833944 — STERILE SOLUTION WARMER
- K832642 — ALPHA-I
- K811524 — AQUACADE
Data sourced from openFDA. This site is unofficial and independent of the FDA.