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510(k) K080023

MODIFICATION TO: SPIRIT by Caire, Inc. — Product Code BYJ

K080023 is an FDA 510(k) premarket notification submitted by Caire, Inc. for the device "MODIFICATION TO: SPIRIT". The FDA issued a decision of Substantially Equivalent on June 16, 2008. The device falls under product code BYJ (Unit, Liquid-Oxygen, Portable), a Class II device regulated under 21 CFR 868.5655. Caire, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2008
Date Received
January 4, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Liquid-Oxygen, Portable
Device Class
Class II
Regulation Number
868.5655
Review Panel
AN
Submission Type

Other clearances by Caire, Inc.

  • K250671 — FreeStyle Comfort (AS200 / FreeStyle Comfort) (July 11, 2025)
  • K120785 — OMNI 3 OXYGEN SYSTEM (October 25, 2012)
  • K121167 — CAIRE COMPANION 5 OXYGEN CONCENTRATOR (May 2, 2012)
  • K050153 — SPIRIT, MODEL HAS (April 15, 2005)
  • K013251 — SPIRIT 300 (December 18, 2001)
  • K952268 — MODEL DELTA, OM OXYGEN CONCENTRATOR (August 11, 1995)

Other clearances for product code BYJ

  • K130068 — DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS) (July 19, 2013)
  • K113767 — MOUNTED MEDICAL OXYGEN SYSTEM (June 29, 2012)
  • K103324 — PRECISION LIQUID OXYGEN SYSTEM (April 21, 2011)
  • K101272 — MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 (August 20, 2010)
  • K081779 — GOLOX-93 (September 19, 2008)
  • K072723 — RESPIRONICS GOLOX (March 20, 2008)
  • K072011 — COPD LIQUID OXYGEN PORTABLE, MODEL 300P (October 18, 2007)
  • K071581 — BACKPACK MEDICAL OXYGEN SYSTEM (July 11, 2007)
  • K050153 — SPIRIT, MODEL HAS (April 15, 2005)
  • K050414 — PLIX (April 11, 2005)

FDA data resources