Home / 510(k) Clearances / K020386

510(k) K020386

INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02 by Invacare Corp. — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2002
Date Received
February 6, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Oxygen, Portable
Device Class
Class II
Regulation Number
868.5440
Review Panel
AN
Submission Type

Other clearances by Invacare Corp.

  • K071928 — THE INVACARE FLYER, MODEL IPC 100 (December 12, 2007)
  • K070321 — TWILIGHT FULL FACE MASK (April 30, 2007)
  • K062402 — EASYSTAND EVOLV (September 21, 2006)
  • K061874 — INVACARE'S TWILIGHT II NASAL MASKS (September 5, 2006)
  • K033819 — INVACARE 3G TARSYS (June 4, 2004)
  • K031176 — INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000 (March 25, 2004)
  • K031064 — INVACARE POLARIS EX CPAP, MODEL ISP3000 (March 12, 2004)
  • K030814 — INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3 (March 20, 2003)
  • K022642 — TWLIGHT, MODEL ISP 9600 (February 11, 2003)
  • K023589 — STORM TDX POWER WHEELCHAIR (November 19, 2002)

Other clearances for product code CAW

  • K251534 — Oxygen Concentrator (J10A) (December 29, 2025)
  • K251764 — Oxygen Concentrator-P2-O5E (December 22, 2025)
  • K252616 — Portable oxygen concentrator (JLO-190P) (December 22, 2025)
  • K252268 — V series portable oxygen concentrator (V5, V5C, V6, V6C) (December 16, 2025)
  • K250805 — DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) (December 9, 2025)
  • K251607 — Oxygen Concentrator (J5A) (November 21, 2025)
  • K243833 — Portable oxygen concentrator (JAY-1000P) (September 29, 2025)
  • K250625 — Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); (August 27, 2025)
  • K251130 — Portable Oxygen Concentrator (JM-P50A) (August 21, 2025)
  • K250671 — FreeStyle Comfort (AS200 / FreeStyle Comfort) (July 11, 2025)