Home / 510(k) Clearances / K021082

510(k) K021082

ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.0 by On Site Gas Systems, Inc. — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2002
Date Received
April 3, 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 On Site Gas Systems, Inc.

  • K092636 — POGS, MODEL 65/130 (January 7, 2010)
  • K063454 — POGS, MODEL 33C (May 9, 2007)
  • K041664 — PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C (July 29, 2004)
  • K030920 — POGS 33 (March 10, 2004)
  • K021581 — HEMOSORB (July 12, 2002)
  • K013390 — QUICKCLOT (May 23, 2002)
  • K020362 — P.O.G.S. 3.3 PORTABLE OXYGEN GENERATOR SYSTEM (February 12, 2002)
  • K014078 — ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM (January 8, 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)