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510(k) K811524

AQUACADE by Respiratory Care, Inc. — Product Code LHC

K811524 is an FDA 510(k) premarket notification submitted by Respiratory Care, Inc. for the device "AQUACADE". The FDA issued a decision of Substantially Equivalent on July 1, 1981. The device falls under product code LHC (Warmer, Irrigation Solution), a Class I device regulated under 21 CFR 890.5950. Respiratory Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1981
Date Received
May 29, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Irrigation Solution
Device Class
Class I
Regulation Number
890.5950
Review Panel
HO
Submission Type

Other clearances by Respiratory Care, Inc.

  • K892230 — RCI VIRAL/BACTERIAL FILTER (August 28, 1989)
  • K884150 — MODIFIED CONCHATHERM III CONTROLLED HEATER (November 21, 1988)
  • K881625 — CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL (June 21, 1988)
  • K864147 — AQUAVALVE (December 5, 1986)
  • K863955 — COLBY LEVEL ALARM (November 7, 1986)
  • K861555 — CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT (June 5, 1986)
  • K834151 — CONCHATHERM LHF HUMIDIFIER HEATER (January 13, 1984)
  • K833974 — AQUAPAK 020 HUMIDIFIER ADAPTER (December 16, 1983)
  • K832453 — SLIMB SINGLE LIMB BREATHING CIRCUIT (October 27, 1983)
  • K811073 — A QUAPAK (April 29, 1981)

Other clearances for product code LHC

  • K153713 — Getinge Series Warming Cabinet (June 7, 2016)
  • K152522 — ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes (January 15, 2016)
  • K150190 — IntraTemp Solution Warmer (February 26, 2015)
  • K142173 — NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE (December 30, 2014)
  • K142080 — NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE (August 28, 2014)
  • K083417 — INTRATEMP SOLUTION WARMER (January 13, 2009)
  • K080609 — SWC/DWC WARMING CABINETS (June 13, 2008)
  • K051819 — C CHANGE SOLUTION WARMER (August 15, 2005)
  • K023283 — 1075LD HUSH-SLUSH (November 13, 2002)
  • K023282 — ORS-3000LD (November 13, 2002)

FDA data resources